Chronic Pain, Low Back Pain, Analgesia
Conditions
Keywords
oxycodone, naltrexone, chronic pain, low back pain
Brief summary
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Interventions
DRUGALO-02
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
DRUGPlacebo
oral placebo, divided into symmetric doses and administered twice daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate-to-severe chronic low back pain present for at least 3 months. * Require a continuous around-the-clock opioid analgesic for an extended period of time. * Refrain from taking other opioid and non-opioid medications during the study.
Exclusion criteria
* Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention. * Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain. * Active or ongoing or history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) | Weeks 11 and 12 | Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Weeks 2, 4, 8, and 12 | Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. |
| Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit). | Week 12 | The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability. |
| Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Randomization Baseline, Week 12 | Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor). |
| Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20% | Weeks 11 and 12 | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain. |
| Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30% | Weeks 11 and 12 | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. |
| Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40% | Weeks 11 and 12 | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. |
| Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50% | Weeks 11 and 12 | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. |
| Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Screening, Week 4, 5, or 6 | BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. |
| Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Screening, Randomization Baseline | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. |
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Weeks 2, 4, 8, and 12 | Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Weeks 2, 4, 8 and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Weeks 2, 4, 8, and 12 | Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Weeks 2, 4, 8, and 12 | Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. |
| Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12) | Randomization Baseline, Weeks 11 and 12 | NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain. |
| Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period | Daily from Day 1 of the Double-Blind Period through Week 12 | The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period. |
| Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Screening, Week 4, 5 or 6 | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100. |
| Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Screening, Week 4, 5, or 6 | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\]. |
| Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Screening, Randomization Baseline (up to 6 weeks) | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. |
| Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Screening, Randomization Baseline (up to 6 weeks) | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\]. |
| Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Randomization Baseline, up to Week 12 | The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\]. |
| Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Randomization Baseline, up to Week 12 | The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\]. |
| Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy | Week 1 up to Week 12 | If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. |
| Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period | Week 1 up to Week 12 | If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the \[date of event or discontinuation - date of first dose in Double-Blind Period +1\]. |
| Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Screening, Weeks 1, 2, 3, 4, 5, and 6 | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. |
| COWS Total Score During the Double-Blind Treatment Period | Randomization Baseline, Weeks 1, 2, 4, 8, and 12 | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. |
| COWS Total Score During the Post-Treatment Period | Follow-Up (FU) Weeks 1 and 2 | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. |
| Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination) | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. |
| Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination) | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. |
| Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | Follow-Up Weeks 1 and 2 | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. |
| Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Screening, Weeks 1, 2, 3, 4, 5, and 6 | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. |
| SOWS Total Score During the Double-Blind Treatment Period | Randomization Baseline, Weeks 1, 2, 4, 8, and 12 | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. |
| SOWS Total Score During the Post-Treatment Period | Follow-Up Weeks 1 and 2 | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. |
| Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants | Screening, Week 6 (or Early Termination) | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability. |
| Change From Screening Period to Randomization Baseline in RMDQ Total Score | Screening, Randomization Baseline | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. |
| Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Screening, Weeks 2, 4, 8, and 12 | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. |
| Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Randomization Baseline, Weeks 2, 4, and 8 | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. |
| Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Screening, Randomization Baseline | Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. |
| Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Screening, Randomization Baseline, or Early Termination | Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. |
| Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Randomization Baseline, Week 4 | Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. |
| Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS | Screening, Week 12 | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. |
| Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Randomization Baseline, Week 8 | Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. |
| Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination) | Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. |
| Satisfaction With Treatment at Randomization Baseline | Randomization Baseline | Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. |
| Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | Week 12 or Early Termination | Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied). |
| Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Screening, Week 6 (or Early Termination) | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state. |
| Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Screening, Randomization Baseline | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. |
| Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Randomization Baseline, Week 12 | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. |
| Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Screening, Week 12 | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. |
| Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index | Screening, Week 6 (or Early Termination) | The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. |
| Median Oxycodone Duration of Titration During the Open-Label Titration Period | Open-Label Period | — |
| Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS | Screening, Week 6 (or Early Termination) | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. |
| Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index | Screening, Randomization Baseline | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health |
| Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS | Screening, Randomization Baseline | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. |
| Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | Randomization Baseline, Week 12 | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health |
| Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS | Randomization Baseline, Week 12 | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. |
| Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | Screening, Week 12 | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. |
| Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | Screening, Week 6 (or Early Termination) | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | Screening, Randomization Baseline | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Randomization Baseline, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Randomization Baseline, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Randomization Baseline, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Randomization Baseline, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Screening, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Screening, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Screening, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Screening, Weeks 4, 8, and 12 | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. |
| Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | Screening, Week 6 (or Early Termination) | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? |
| Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Screening, Randomization Baseline | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? |
| Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Screening, Randomization Baseline | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain. |
| Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Screening, Randomization Baseline | Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain |
| Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital | Screening, Randomization Baseline | Question 3b: nights stayed in the hospital, if answer to Q3a was yes. |
| Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Screening, Week 6 (or Early Termination) | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain. |
| Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Screening, Week 6 (or Early Termination) | Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain |
| Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital | Screening, Week 6 (or Early Termination) | Question 3b: nights stayed in the hospital, if answer to Q3a was yes. |
| Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination) | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Randomization Baseline, Weeks 4, 8, and 12 | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Randomization Baseline, Weeks 4, 8, and 12 | Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain. |
| Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Randomization Baseline, Weeks 4, 8, and 12 | Question 3b: nights stayed in the hospital |
| Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Screening, Weeks 4, 8, and 12 | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? |
| Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Screening, Weeks 4, 8, and 12 | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain |
| Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Screening, Weeks 4, 8, and 12 | Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain |
| Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Weeks 2, 4, 8, and 12 | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. |
| Mean Oxycodone Average Daily Dose During the Open-Label Titration Period | Open-Label Period | — |
| Mean Oxycodone Duration of Titration During the Open-Label Titration Period | Open-Label Period | — |
| Median Oxycodone Average Daily Dose During the Open-Label Titration Period | Open-Label Period | — |
| Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period | Double-Blind Period | — |
| Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period | Double-Blind Period | — |
| Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period | Double-Blind Period | — |
| Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period | Double-Blind Period | — |
| Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline | Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone. |
| Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline | Cobs of naltrexone and 6-β-naltrexol |
| Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 | Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone |
| Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 | Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol |
| Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Screening, Weeks 4, 8, and 12 | Question 3b: nights stayed in the hospital |
Countries
United States
Participant flow
Recruitment details
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of ALO-02 Extended-Release Capsules in participants with Moderate to Severe Chronic Low Back Pain
Pre-assignment details
A total of 410 participants were enrolled into the Open-Label Conversion and Titration Period and 281 participants were randomized into the Double-Blind Treatment Period, of which, 280 participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Open ALO-02 Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. | 410 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind Treatment Period | Adverse Event | 0 | 9 | 14 |
| Double-Blind Treatment Period | Insufficient clinical response | 0 | 16 | 4 |
| Double-Blind Treatment Period | Lost to Follow-up | 0 | 3 | 6 |
| Double-Blind Treatment Period | Other - unspecified | 0 | 6 | 1 |
| Double-Blind Treatment Period | Protocol Violation | 0 | 8 | 9 |
| Double-Blind Treatment Period | Withdrawal by Subject | 0 | 11 | 5 |
| Open-Label Conversion + Titration Period | Adverse Event | 57 | 0 | 0 |
| Open-Label Conversion + Titration Period | Does not meet entrance criteria | 41 | 0 | 0 |
| Open-Label Conversion + Titration Period | Lost to Follow-up | 10 | 0 | 0 |
| Open-Label Conversion + Titration Period | Other - unspecified | 3 | 0 | 0 |
| Open-Label Conversion + Titration Period | Protocol Violation | 7 | 0 | 0 |
| Open-Label Conversion + Titration Period | Withdrawal by Subject | 11 | 0 | 0 |
Baseline characteristics
| Characteristic | Open ALO-02 |
|---|---|
| Age, Customized >=65 years | 46 Participants |
| Age, Customized Between 18 and 65 years | 364 Participants |
| Sex: Female, Male Female | 233 Participants |
| Sex: Female, Male Male | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 186 / 410 | 26 / 134 | 41 / 146 |
| serious Total, serious adverse events | 3 / 410 | 2 / 134 | 5 / 146 |
Outcome results
Primary
Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)
Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
Time frame: Weeks 11 and 12
Population: Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) | 1.23 Units on a Scale | Standard Error 0.179 |
| ALO-02 To ALO-02 | Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) | 0.60 Units on a Scale | Standard Error 0.168 |
Comparison: Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.p-value: 0.011495% CI: [-1.11, -0.14]ANCOVA
Secondary
Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)
NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.
Time frame: Randomization Baseline, Weeks 11 and 12
Population: ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12) | 39.00 Change in units on a scale*days | Standard Error 7.914 |
| ALO-02 To ALO-02 | Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12) | 11.25 Change in units on a scale*days | Standard Error 7.636 |
p-value: 0.01295% CI: [-49.34, -6.16]ANCOVA
Secondary
Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period
The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.
Time frame: Daily from Day 1 of the Double-Blind Period through Week 12
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period | 207.84 Average mg/day | Standard Error 36.436 |
| ALO-02 To ALO-02 | Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period | 203.97 Average mg/day | Standard Error 34.851 |
p-value: 0.93995% CI: [-103.29, 95.55]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health
Time frame: Randomization Baseline, Week 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | -0.061 Score on a scale | Standard Error 0.0118 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | -0.029 Score on a scale | Standard Error 0.012 |
p-value: 0.060595% CI: [-0.001, 0.065]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS
The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time frame: Randomization Baseline, Week 12
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS | -3.61 Score on a scale | Standard Error 1.432 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS | -2.89 Score on a scale | Standard Error 1.401 |
p-value: 0.719695% CI: [-3.22, 4.66]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 2 (n=125,135) | 1.01 Units on a Scale | Standard Error 0.137 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 4 (n=111,124) | 1.04 Units on a Scale | Standard Error 0.156 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 8 (n=88,112) | 0.99 Units on a Scale | Standard Error 0.179 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 12/ET (n=131,138) | 1.27 Units on a Scale | Standard Error 0.159 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 12/ET (n=131,138) | 0.39 Units on a Scale | Standard Error 0.154 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 2 (n=125,135) | 0.36 Units on a Scale | Standard Error 0.132 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 8 (n=88,112) | 0.35 Units on a Scale | Standard Error 0.157 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 4 (n=111,124) | 0.30 Units on a Scale | Standard Error 0.147 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2.p-value: 0.000795% CI: [-1.02, -0.27]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4.p-value: 0.000695% CI: [-1.16, -0.32]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.00795% CI: [-1.11, -0.18]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: <0.000195% CI: [-1.31, -0.44]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 2 (n=126,135) | 0.74 Units on a Scale | Standard Error 0.139 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 4 (n=111,125) | 0.94 Units on a Scale | Standard Error 0.147 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 8 (n=89,112) | 0.83 Units on a Scale | Standard Error 0.171 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 12/ET(n=131,138) | 1.13 Units on a Scale | Standard Error 0.151 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 12/ET(n=131,138) | 0.28 Units on a Scale | Standard Error 0.147 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 2 (n=126,135) | 0.34 Units on a Scale | Standard Error 0.134 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 8 (n=89,112) | 0.19 Units on a Scale | Standard Error 0.151 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 4 (n=111,125) | 0.06 Units on a Scale | Standard Error 0.138 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2p-value: 0.041295% CI: [-0.78, -0.02]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4p-value: <0.000195% CI: [-1.27, -0.48]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.005595% CI: [-1.08, -0.19]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: <0.000195% CI: [-1.27, -0.44]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 2 (n=126,135) | 0.77 Units on a Scale | Standard Error 0.135 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 4 (n=111,127) | 0.92 Units on a Scale | Standard Error 0.139 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 8 (n=89,113) | 0.64 Units on a Scale | Standard Error 0.168 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 12/ET (n=131,138) | 1.14 Units on a Scale | Standard Error 0.149 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 12/ET (n=131,138) | 0.49 Units on a Scale | Standard Error 0.145 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 2 (n=126,135) | 0.36 Units on a Scale | Standard Error 0.13 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 8 (n=89,113) | 0.47 Units on a Scale | Standard Error 0.148 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 4 (n=111,127) | 0.43 Units on a Scale | Standard Error 0.129 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2.p-value: 0.028595% CI: [-0.78, -0.04]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4.p-value: 0.010695% CI: [-0.85, -0.11]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.452995% CI: [-0.6, 0.27]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: 0.001895% CI: [-1.06, -0.25]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 2 (n=126,135) | 1.04 Units on a Scale | Standard Error 0.149 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 4 (n=111,125) | 1.03 Units on a Scale | Standard Error 0.157 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 8 (n=88,112) | 1.04 Units on a Scale | Standard Error 0.2 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 12/ET (n=131,138) | 1.43 Units on a Scale | Standard Error 0.166 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 12/ET (n=131,138) | 0.36 Units on a Scale | Standard Error 0.161 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 2 (n=126,135) | 0.40 Units on a Scale | Standard Error 0.144 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 8 (n=88,112) | 0.33 Units on a Scale | Standard Error 0.176 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 4 (n=111,125) | 0.24 Units on a Scale | Standard Error 0.148 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2.p-value: 0.002295% CI: [-1.05, -0.23]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4.p-value: 0.000395% CI: [-1.21, -0.37]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.007895% CI: [-1.23, -0.19]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: <0.000195% CI: [-1.52, -0.62]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 2 (n=125,135) | 0.95 Units on a Scale | Standard Error 0.136 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 4 (n=111,124) | 1.04 Units on a Scale | Standard Error 0.145 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 8 (n=88,112) | 0.95 Units on a Scale | Standard Error 0.173 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 12/ET (n=131,138) | 1.32 Units on a Scale | Standard Error 0.149 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 12/ET (n=131,138) | 0.38 Units on a Scale | Standard Error 0.144 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 2 (n=125,135) | 0.37 Units on a Scale | Standard Error 0.131 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 8 (n=88,112) | 0.34 Units on a Scale | Standard Error 0.152 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 4 (n=111,124) | 0.28 Units on a Scale | Standard Error 0.137 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2.p-value: 0.002295% CI: [-0.95, -0.21]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4.p-value: 0.000295% CI: [-1.15, -0.37]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.007895% CI: [-1.06, -0.16]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: <0.000195% CI: [-1.35, -0.54]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 2 (n=126,135) | 1.00 Units on a Scale | Standard Error 0.16 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 4 (n=111,125) | 1.15 Units on a Scale | Standard Error 0.179 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 8 (n=89,113) | 0.86 Units on a Scale | Standard Error 0.205 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 12/Early Termination (ET)(n=131,138) | 1.45 Units on a Scale | Standard Error 0.176 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 12/Early Termination (ET)(n=131,138) | 0.47 Units on a Scale | Standard Error 0.17 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 2 (n=126,135) | 0.38 Units on a Scale | Standard Error 0.155 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 8 (n=89,113) | 0.49 Units on a Scale | Standard Error 0.18 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 4 (n=111,125) | 0.51 Units on a Scale | Standard Error 0.168 |
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 2.p-value: 0.005695% CI: [-1.06, -0.18]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 4.p-value: 0.00995% CI: [-1.12, -0.16]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 8.p-value: 0.168495% CI: [-0.91, 0.16]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.p-value: <0.000195% CI: [-1.46, -0.5]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments
Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 4 (n=99,117) | -24.7 Dollars | Standard Deviation 222.07 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 8 (n=76,105) | -0.1 Dollars | Standard Deviation 71.11 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 4 (n=104,119) | 19.9 Dollars | Standard Deviation 90.26 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 12/ET (n=125,133) | 113.0 Dollars | Standard Deviation 913.41 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 8 (n=81,106) | 146.2 Dollars | Standard Deviation 1113.58 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 12/ET (n=119,128) | -47.8 Dollars | Standard Deviation 461.95 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Randomization Baseline (n=124,136) | 96.4 Dollars | Standard Deviation 518.89 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 12/ET (n=119,128) | 20.0 Dollars | Standard Deviation 180.7 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Randomization Baseline (n=124,136) | 11.3 Dollars | Standard Deviation 33.77 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 4 (n=104,119) | 15.0 Dollars | Standard Deviation 78.59 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 4 (n=99,117) | 4.4 Dollars | Standard Deviation 79.92 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 8 (n=81,106) | 16.7 Dollars | Standard Deviation 54.33 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Change from Baseline at Week 8 (n=76,105) | 7.5 Dollars | Standard Deviation 42.52 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Week 12/ET (n=125,133) | 29.3 Dollars | Standard Deviation 177.85 |
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital
Question 3b: nights stayed in the hospital
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 4 (n=4,0) | 0.3 Number of nights | Standard Deviation 0.5 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 8 (n=0,0) | NA Number of nights | — |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 4 (n=0,0) | NA Number of nights | — |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 12/ET (n=4,1) | 24.8 Number of nights | Standard Deviation 49.5 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Randomization Baseline (n=1,2) | 0.0 Number of nights | — |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 12/ET (n=0,0) | NA Number of nights | — |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 8 (n=1,1) | 99.0 Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 12/ET (n=0,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Randomization Baseline (n=1,2) | 0.0 Number of nights | Standard Deviation 0 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 4 (n=0,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 8 (n=1,1) | 0.0 Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Change from Baseline at Week 8 (n=0,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 12/ET (n=4,1) | 0.0 Number of nights | — |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Week 4 (n=4,0) | NA Number of nights | — |
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain
Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 4 (n=95,106) | 0.1 Number of visits | Standard Deviation 24.17 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 8 (n=74,100) | -1.2 Number of visits | Standard Deviation 20.35 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 4 (n=100,110) | 6.5 Number of visits | Standard Deviation 24.35 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 12/ET (n=121,128) | 19.2 Number of visits | Standard Deviation 153.8 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 8 (n=79,103) | 22.8 Number of visits | Standard Deviation 179.55 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 12/ET (n=112,119) | -0.3 Number of visits | Standard Deviation 24.9 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Randomization Baseline (n=118,129) | 4.4 Number of visits | Standard Deviation 18.1 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 12/ET (n=112,119) | -4.1 Number of visits | Standard Deviation 27.74 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Randomization Baseline (n=118,129) | 6.6 Number of visits | Standard Deviation 24.8 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 4 (n=100,110) | 5.3 Number of visits | Standard Deviation 37.99 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 4 (n=95,106) | -3.1 Number of visits | Standard Deviation 46.85 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 8 (n=79,103) | 3.3 Number of visits | Standard Deviation 13.46 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Change from Baseline at Week 8 (n=74,100) | -2.6 Number of visits | Standard Deviation 24.31 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Week 12/ET (n=121,128) | 4.2 Number of visits | Standard Deviation 15.38 |
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 4 (n=108,125) | 6.23 Percentage | Standard Error 1.768 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 8 (n=85,112) | 2.05 Percentage | Standard Error 2.044 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 12/ET (n=128,135) | 10.56 Percentage | Standard Error 1.818 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 4 (n=108,125) | 1.98 Percentage | Standard Error 1.626 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 8 (n=85,112) | 3.05 Percentage | Standard Error 1.752 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 12/ET (n=128,135) | 6.41 Percentage | Standard Error 1.758 |
Comparison: Week 4p-value: 0.076895% CI: [-8.95, 0.46]ANCOVA
Comparison: Week 8p-value: 0.710995% CI: [-4.3, 6.29]ANCOVA
Comparison: Week 12/ETp-value: 0.103195% CI: [-9.14, 0.85]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 4 (n=30,42) | 5.22 Percentage | Standard Error 3.366 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 8 (n=21,37) | 3.63 Percentage | Standard Error 4.318 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 12/ET (n=35,46) | 6.77 Percentage | Standard Error 3.475 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 4 (n=30,42) | -1.54 Percentage | Standard Error 2.734 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 8 (n=21,37) | -1.36 Percentage | Standard Error 3.027 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 12/ET (n=35,46) | 4.39 Percentage | Standard Error 2.918 |
Comparison: Week 4p-value: 0.120195% CI: [-15.33, 1.81]ANCOVA
Comparison: Week 8p-value: 0.349795% CI: [-15.6, 5.62]ANCOVA
Comparison: Week 12/ETp-value: 0.600895% CI: [-11.41, 6.65]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 4 (n=30,42) | 5.31 Percentage | Standard Error 3.894 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 8 (n=21,37) | 8.69 Percentage | Standard Error 5.276 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 12/ET (n=35,46) | 10.85 Percentage | Standard Error 4.266 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 4 (n=30,42) | -2.03 Percentage | Standard Error 3.147 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 8 (n=21,37) | -0.66 Percentage | Standard Error 3.666 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 12/ET (n=35,46) | 5.71 Percentage | Standard Error 3.575 |
Comparison: Week 4p-value: 0.145895% CI: [-17.29, 2.62]ANCOVA
Comparison: Week 8p-value: 0.155895% CI: [-22.38, 3.68]ANCOVA
Comparison: Week 12/ETp-value: 0.360495% CI: [-16.25, 5.98]ANCOVA
Secondary
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Randomization Baseline, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 4 (n=36,44) | 3.54 Percentage | Standard Error 2.213 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 8 (n=25,41) | 4.29 Percentage | Standard Error 3.507 |
| ALO-02 To Placebo | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 12/ET (n=40,50) | 6.49 Percentage | Standard Error 3.108 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 4 (n=36,44) | -0.77 Percentage | Standard Error 1.906 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 8 (n=25,41) | 1.41 Percentage | Standard Error 2.592 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 12/ET (n=40,50) | 3.72 Percentage | Standard Error 2.675 |
Comparison: Week 4p-value: 0.138995% CI: [-10.06, 1.43]ANCOVA
Comparison: Week 8p-value: 0.509495% CI: [-11.56, 5.8]ANCOVA
Comparison: Week 12/ETp-value: 0.494495% CI: [-10.81, 5.26]ANCOVA
Secondary
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time frame: Randomization Baseline, Week 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Functioning (n=122,125) | -2.06 Score on a scale | Standard Error 0.681 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Physical (n=124,126) | -2.56 Score on a scale | Standard Error 0.713 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Bodily Pain (n=124,127) | -5.07 Score on a scale | Standard Error 0.655 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | General Health Perceptions (n=124,126) | -1.55 Score on a scale | Standard Error 0.545 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Vitality (n=123,127) | -1.62 Score on a scale | Standard Error 0.781 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Social Functioning (n=124,127) | -3.17 Score on a scale | Standard Error 0.748 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Emotional (n=124,127) | -2.57 Score on a scale | Standard Error 0.963 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Health (n=124,127) | -2.95 Score on a scale | Standard Error 0.711 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Component Score (n=121,125) | -2.70 Score on a scale | Standard Error 0.635 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Component Score (n=121,125) | -2.29 Score on a scale | Standard Error 0.767 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Health (n=124,127) | -2.93 Score on a scale | Standard Error 0.697 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Functioning (n=122,125) | -1.44 Score on a scale | Standard Error 0.666 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Social Functioning (n=124,127) | -1.69 Score on a scale | Standard Error 0.734 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Physical (n=124,126) | -2.59 Score on a scale | Standard Error 0.701 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Component Score (n=121,125) | -2.98 Score on a scale | Standard Error 0.749 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Bodily Pain (n=124,127) | -2.69 Score on a scale | Standard Error 0.643 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Emotional (n=124,127) | -3.44 Score on a scale | Standard Error 0.943 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | General Health Perceptions (n=124,126) | -2.10 Score on a scale | Standard Error 0.536 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Component Score (n=121,125) | -1.68 Score on a scale | Standard Error 0.62 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Vitality (n=123,127) | -2.77 Score on a scale | Standard Error 0.762 |
Comparison: Difference between treatment groups in change from Randomization Baseline for Physical Functioning.p-value: 0.518195% CI: [-1.26, 2.49]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Role-Physical.p-value: 0.973395% CI: [-2, 1.93]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Bodily Pain.p-value: 0.0195% CI: [0.57, 4.18]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.p-value: 0.471295% CI: [-2.06, 0.95]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Vitality.p-value: 0.289895% CI: [-3.3, 0.99]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Social Functioning.p-value: 0.156595% CI: [-0.57, 3.54]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Role-Emotional.p-value: 0.52295% CI: [-3.52, 1.79]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Mental Health.p-value: 0.986595% CI: [-1.94, 1.98]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Physical Component Score.p-value: 0.249195% CI: [-0.72, 2.77]ANCOVA
Comparison: Difference between treatment groups in change from Randomization Baseline for Mental Component Score.p-value: 0.521995% CI: [-2.8, 1.43]ANCOVA
Secondary
Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score
RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time frame: Randomization Baseline, Weeks 2, 4, and 8
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 2 (n=111,118) | 0.54 Units on a scale | Standard Error 0.334 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 4 (n=98,107) | 1.02 Units on a scale | Standard Error 0.42 |
| ALO-02 To Placebo | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 8 (n=73,93) | -0.01 Units on a scale | Standard Error 0.471 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 2 (n=111,118) | -0.19 Units on a scale | Standard Error 0.321 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 4 (n=98,107) | 0.32 Units on a scale | Standard Error 0.397 |
| ALO-02 To ALO-02 | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | Week 8 (n=73,93) | 0.41 Units on a scale | Standard Error 0.408 |
Comparison: Model-adjusted change from Baseline to Week 2.p-value: 0.113995% CI: [-1.65, 0.18]ANCOVA
Comparison: Model-adjusted Change from Baseline to Week 4.p-value: 0.226495% CI: [-1.84, 0.44]ANCOVA
Comparison: Model-adjusted Change from Baseline to Week 8.p-value: 0.507495% CI: [-0.81, 1.63]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
Time frame: Screening, Week 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | 0.085 Score on a scale | Standard Error 0.0121 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | 0.106 Score on a scale | Standard Error 0.0124 |
p-value: 0.22895% CI: [-0.013, 0.055]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS
The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time frame: Screening, Week 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS | 4.75 Score on a scale | Standard Error 1.465 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS | 7.01 Score on a scale | Standard Error 1.454 |
p-value: 0.270195% CI: [-1.77, 6.3]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time frame: Screening, Week 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Functioning (n=123,126) | 5.32 Score on a scale | Standard Error 0.794 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Physical (n=125,127) | 5.68 Score on a scale | Standard Error 0.805 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Bodily Pain (n=125,127) | 6.39 Score on a scale | Standard Error 0.747 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | General Health Perceptions (n=125,126) | 1.28 Score on a scale | Standard Error 0.611 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Vitality (n=125,127) | 3.46 Score on a scale | Standard Error 0.798 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Social Functioning (n=125,127) | 3.58 Score on a scale | Standard Error 0.771 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Emotional (n=125,127) | 0.99 Score on a scale | Standard Error 0.979 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Health (n=125,127) | 0.09 Score on a scale | Standard Error 0.752 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Component Score (n=123,126) | 6.42 Score on a scale | Standard Error 0.721 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Component Score (n=123,126) | -0.44 Score on a scale | Standard Error 0.816 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Health (n=125,127) | 0.47 Score on a scale | Standard Error 0.748 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Functioning (n=123,126) | 6.84 Score on a scale | Standard Error 0.787 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Social Functioning (n=125,127) | 5.57 Score on a scale | Standard Error 0.768 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Physical (n=125,127) | 6.78 Score on a scale | Standard Error 0.802 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Mental Component Score (n=123,126) | -0.45 Score on a scale | Standard Error 0.808 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Bodily Pain (n=125,127) | 8.78 Score on a scale | Standard Error 0.743 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Role-Emotional (n=125,127) | 1.22 Score on a scale | Standard Error 0.975 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | General Health Perceptions (n=125,126) | 1.07 Score on a scale | Standard Error 0.609 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Physical Component Score (n=123,126) | 8.09 Score on a scale | Standard Error 0.715 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | Vitality (n=125,127) | 3.01 Score on a scale | Standard Error 0.794 |
Comparison: Difference between treatment groups in change from Screening for Physical Functioning.p-value: 0.173195% CI: [-0.67, 3.71]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Role-Physical.p-value: 0.32995% CI: [-1.12, 3.32]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Bodily Pain.p-value: 0.023295% CI: [0.33, 4.45]ANCOVA
Comparison: Difference between treatment groups in change from Screening for General Health Perceptions.p-value: 0.813995% CI: [-1.89, 1.49]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Vitality.p-value: 0.687895% CI: [-2.65, 1.75]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Social Functioning.p-value: 0.065895% CI: [-0.13, 4.12]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Role-Emotional.p-value: 0.86795% CI: [-2.48, 2.94]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Mental Health.p-value: 0.725995% CI: [-1.71, 2.45]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Physical Component Score.p-value: 0.098995% CI: [-0.32, 3.65]ANCOVA
Comparison: Difference between treatment groups in change from Screening for Mental Component Score.p-value: 0.996995% CI: [-2.25, 2.25]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score
RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time frame: Screening, Weeks 2, 4, 8, and 12
Population: ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 8 (n=77,95) | -4.50 Units on a scale | Standard Error 0.514 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 2 (n=114,124) | -3.88 Units on a scale | Standard Error 0.423 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 12/ET (n=123,128) | -4.33 Units on a scale | Standard Error 0.44 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 4 (n=101,111) | -3.90 Units on a scale | Standard Error 0.467 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 12/ET (n=123,128) | -4.26 Units on a scale | Standard Error 0.431 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 2 (n=114,124) | -4.93 Units on a scale | Standard Error 0.406 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 8 (n=77,95) | -3.92 Units on a scale | Standard Error 0.459 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | Week 4 (n=101,111) | -4.60 Units on a scale | Standard Error 0.444 |
Comparison: Model-adjusted Change from Screening to Week 2.p-value: 0.073395% CI: [-2.2, 0.1]ANCOVA
Comparison: Model-adjusted Change from Screening to Week 4.p-value: 0.278395% CI: [-1.96, 0.57]ANCOVA
Comparison: Model-adjusted Change from Screening to Week 8.p-value: 0.395195% CI: [-0.77, 1.93]ANCOVA
Comparison: Model-adjusted Change from Screening to Week 12.p-value: 0.906395% CI: [-1.14, 1.28]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain
Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 4 (n=100,114) | -79.8 Dollars | Standard Deviation 315.79 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 8 (n=78,103) | 56.9 Dollars | Standard Deviation 1174.87 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 4 (n=104,119) | 19.9 Dollars | Standard Deviation 90.26 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 12/ET (n=125,133) | 113.0 Dollars | Standard Deviation 913.41 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 8 (n=81,106) | 146.2 Dollars | Standard Deviation 1113.58 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=120,128) | 32.1 Dollars | Standard Deviation 944.71 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Screening (n=126,138) | 83.6 Dollars | Standard Deviation 277.98 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=120,128) | -58.1 Dollars | Standard Deviation 563.65 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Screening (n=126,138) | 85.6 Dollars | Standard Deviation 514.8 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 4 (n=104,119) | 15.0 Dollars | Standard Deviation 78.59 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 4 (n=100,114) | -80.3 Dollars | Standard Deviation 497.56 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 8 (n=81,106) | 16.7 Dollars | Standard Deviation 54.33 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Change from Screening at Week 8 (n=78,103) | -84.5 Dollars | Standard Deviation 593.49 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Week 12/ET (n=125,133) | 29.3 Dollars | Standard Deviation 177.85 |
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain
Question 3b: nights stayed in the hospital
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 4 (n=1,0) | 0.0 Number of nights | — |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 8 (n=0,0) | NA Number of nights | — |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 4 (n=4,0) | 0.3 Number of nights | Standard Deviation 0.5 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 12/ET (n=4,1) | 24.8 Number of nights | Standard Deviation 49.5 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 8 (n=1,1) | 99.0 Number of nights | — |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=1,0) | 0.0 Number of nights | — |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Screening (n=6,3) | 0.0 Number of nights | Standard Deviation 0 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=1,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Screening (n=6,3) | 0.3 Number of nights | Standard Deviation 0.58 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 4 (n=4,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 4 (n=1,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 8 (n=1,1) | 0.0 Number of nights | — |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Change from Screening at Week 8 (n=0,0) | NA Number of nights | — |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Week 12/ET (n=4,1) | 0.0 Number of nights | — |
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain
Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 4 (n=94,106) | 0.8 Number of visits | Standard Deviation 28.99 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 8 (n=73,100) | 16.7 Number of visits | Standard Deviation 188.74 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 4 (n=100,110) | 6.5 Number of visits | Standard Deviation 24.35 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 12/ET (n=121,128) | 19.2 Number of visits | Standard Deviation 153.8 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 8 (n=79,103) | 22.8 Number of visits | Standard Deviation 179.55 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=114,123) | 13.2 Number of visits | Standard Deviation 159.55 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Screening (n=121,136) | 8.8 Number of visits | Standard Deviation 33.76 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 12/ET (n=114,123) | -7.3 Number of visits | Standard Deviation 41.8 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Screening (n=121,136) | 13.7 Number of visits | Standard Deviation 43.07 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 4 (n=100,110) | 5.3 Number of visits | Standard Deviation 37.99 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 4 (n=94,106) | -7.6 Number of visits | Standard Deviation 58.56 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 8 (n=79,103) | 3.3 Number of visits | Standard Deviation 13.46 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Change from Screening at Week 8 (n=73,100) | -10.4 Number of visits | Standard Deviation 44.61 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Week 12/ET (n=121,128) | 4.2 Number of visits | Standard Deviation 15.38 |
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 4 (n=109,125) | -23.75 Percentage | Standard Error 1.96 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 8 (n=87,112) | -25.25 Percentage | Standard Error 2.279 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 12/ET (n=130,136) | -18.62 Percentage | Standard Error 2.025 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 4 (n=109,125) | -31.24 Percentage | Standard Error 1.829 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 8 (n=87,112) | -29.87 Percentage | Standard Error 2.005 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | Week 12/ET (n=130,136) | -26.81 Percentage | Standard Error 1.981 |
Comparison: Week 4p-value: 0.005295% CI: [-12.72, -2.27]ANCOVA
Comparison: Week 8p-value: 0.124995% CI: [-10.54, 1.29]ANCOVA
Comparison: Week 12/ETp-value: 0.00495% CI: [-13.74, -2.64]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 4 (n=33,42) | -18.65 Percentage | Standard Error 3.614 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 8 (n=22,37) | -16.43 Percentage | Standard Error 4.374 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 12/ET (n=38,46) | -16.18 Percentage | Standard Error 3.642 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 4 (n=33,42) | -31.03 Percentage | Standard Error 3.151 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 8 (n=22,37) | -29.37 Percentage | Standard Error 3.263 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | Week 12/ET (n=38,46) | -25.38 Percentage | Standard Error 3.242 |
Comparison: Week 4p-value: 0.009895% CI: [-21.68, -3.07]ANCOVA
Comparison: Week 8p-value: 0.018695% CI: [-23.63, -2.25]ANCOVA
Comparison: Week 12/ETp-value: 0.058195% CI: [-18.72, 0.32]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 8 (n=21,37) | -15.21 Percentage | Standard Error 4.933 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 12/ET (n=37,46) | -15.16 Percentage | Standard Error 4.268 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 4 (n=32,41) | -19.84 Percentage | Standard Error 3.992 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 4 (n=32,41) | -32.40 Percentage | Standard Error 3.47 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 8 (n=21,37) | -29.37 Percentage | Standard Error 3.608 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | Week 12/ET (n=37,46) | -25.51 Percentage | Standard Error 3.759 |
Comparison: Week 4p-value: 0.017795% CI: [-22.87, -2.25]ANCOVA
Comparison: Week 8p-value: 0.021995% CI: [-26.19, -2.14]ANCOVA
Comparison: Week 12/ETp-value: 0.067995% CI: [-21.47, 0.78]ANCOVA
Secondary
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 4 (n=36,43) | -0.09 Percentage | Standard Error 2.147 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 8 (n=24,40) | -1.42 Percentage | Standard Error 2.785 |
| ALO-02 To Placebo | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 12/ET (n=40,49) | -1.00 Percentage | Standard Error 2.612 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 4 (n=36,43) | -4.82 Percentage | Standard Error 1.911 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 8 (n=24,40) | -3.01 Percentage | Standard Error 2.123 |
| ALO-02 To ALO-02 | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | Week 12/ET (n=40,49) | -2.09 Percentage | Standard Error 2.307 |
Comparison: Week 4p-value: 0.092695% CI: [-10.26, 0.8]ANCOVA
Comparison: Week 8p-value: 0.643795% CI: [-8.42, 5.24]ANCOVA
Comparison: Week 12/ETp-value: 0.74895% CI: [-7.84, 5.65]ANCOVA
Secondary
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | Percent Work Time Missed (n=119) | -1.3 Percentage | Standard Deviation 16.66 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | Percent Impairment While Working (n=112) | -22.4 Percentage | Standard Deviation 26.95 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | Percent Overall Work Impairment (n=110) | -21.6 Percentage | Standard Deviation 29.83 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | Percent Activity Impairment (n=363) | -27.2 Percentage | Standard Deviation 24.45 |
Comparison: Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.p-value: 0.3822t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants
RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants | Screening (n=405) | 12.7 Units on a scale | Standard Deviation 5.42 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants | End of Open-Label Titration Period (n=345) | 9.0 Units on a scale | Standard Deviation 5.62 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants | Change from Screening (n=343) | -3.9 Units on a scale | Standard Deviation 4.91 |
Comparison: Change from Screening Period value to the End of Open-Label Titration Period.p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time frame: Screening, Week 4, 5, or 6
Population: Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Worst Pain Score (n=400) | -3.3 Units on a Scale | Standard Deviation 2.3 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Least Pain Score (n=400) | -2.6 Units on a Scale | Standard Deviation 2.33 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Average Pain Score (n=400) | -3.0 Units on a Scale | Standard Deviation 2.11 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Right Now (n=400) | -3.3 Units on a Scale | Standard Deviation 2.41 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Severity Index (n=400) | -3.1 Units on a Scale | Standard Deviation 2.07 |
| ALO-02 To Placebo | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Interference Index (n=401) | -2.8 Units on a Scale | Standard Deviation 2.32 |
Comparison: Change from Screening Period value to end of the OL Period for Worst Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to end of the OL Period for Least Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to end of the OL Period for Average Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to end of the OL Period for Pain Right Nowp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to end of the OL Period for Pain Severity Indexp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to end of the OL Period for Pain Interference Indexp-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time frame: Screening, Randomization Baseline
Population: ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Worst Pain Score (n=279) | -4.2 units on scale | Standard Deviation 1.83 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Least Pain Score (n=279) | -3.4 units on scale | Standard Deviation 2.04 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Average Pain Score (n=279) | -3.8 units on scale | Standard Deviation 1.6 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Right Now (n=279) | -4.2 units on scale | Standard Deviation 1.95 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Severity Index (n=279) | -3.9 units on scale | Standard Deviation 1.63 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | Pain Interference Index (n=279) | -3.4 units on scale | Standard Deviation 2.16 |
Comparison: Change from Screening Period value to Randomization Baseline for Worst Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for Least Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for Average Pain Scorep-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for Pain Right Nowp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for Pain Severity Indexp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for Pain Interference Indexp-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index
Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index | Screening (n=272) | 0.68 Score on a scale | Standard Deviation 0.178 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index | Randomization Baseline (n=267) | 0.82 Score on a scale | Standard Deviation 0.12 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index | Change from Screening (n=260) | 0.14 Score on a scale | Standard Deviation 0.177 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS
The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS | Screening (n=279) | 67.02 Score on a scale | Standard Deviation 18.518 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS | Randomization Baseline (n=276) | 76.85 Score on a scale | Standard Deviation 17.407 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS | Change from Screening (n=275) | 9.84 Score on a scale | Standard Deviation 19.692 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in RMDQ Total Score
RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in RMDQ Total Score | Screening (n=277) | 12.8 Units on a scale | Standard Deviation 5.22 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in RMDQ Total Score | Randomization Baseline (n=256) | 7.9 Units on a scale | Standard Deviation 5.14 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in RMDQ Total Score | Change from Screening (n=255) | -4.8 Units on a scale | Standard Deviation 4.95 |
Comparison: Change from Screening Period value to Randomization Baseline.p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score
SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Physical Functioning (n=276) | 8.0 Score on a scale | Standard Deviation 8.9 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Role-Physical (n=276) | 9.1 Score on a scale | Standard Deviation 9.4 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Bodily Pain (n=276) | 11.6 Score on a scale | Standard Deviation 7.91 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | General Health (n=277) | 3.1 Score on a scale | Standard Deviation 6.65 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Vitality (n=276) | 5.8 Score on a scale | Standard Deviation 9.08 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Social Functioning (n=277) | 7.0 Score on a scale | Standard Deviation 10.27 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Role-Emotional (n=277) | 4.7 Score on a scale | Standard Deviation 12.04 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Mental Health (n=277) | 3.5 Score on a scale | Standard Deviation 8.29 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Physical Component Score (n=274) | 9.6 Score on a scale | Standard Deviation 7.77 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | Mental Component Score (n=274) | 2.9 Score on a scale | Standard Deviation 9.69 |
Comparison: Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Scorep-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain
A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | Percent Work Time Missed (n=91) | -4.9 Percentage | Standard Deviation 14.37 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | Percent Impairment While Working (n=86) | -25.9 Percentage | Standard Deviation 27.24 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | Percent Overall Work Impairment (n=85) | -26.9 Percentage | Standard Deviation 27.76 |
| ALO-02 To Placebo | Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | Percent Activity Impairment (n=273) | -32.0 Percentage | Standard Deviation 23.96 |
Comparison: Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Painp-value: 0.0017t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Painp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Painp-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Painp-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS
The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS | Screening (n=406) | 66.23 Score on a scale | Standard Deviation 18.277 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS | End of Open-Label (n=367) | 74.69 Score on a scale | Standard Deviation 18.204 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS | Change from Screening (n=364) | 8.16 Score on a scale | Standard Deviation 19.398 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index
The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index | Screening (n=400) | 0.68 Score on a scale | Standard Deviation 0.174 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index | End of Open-Label (n=354) | 0.80 Score on a scale | Standard Deviation 0.134 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index | Change from Screening (n=346) | 0.12 Score on a scale | Standard Deviation 0.174 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score
SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Physical Functioning (n=366) | 6.7 Score on a scale | Standard Deviation 8.96 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Role-Physical (n=366) | 7.7 Score on a scale | Standard Deviation 9.48 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Bodily Pain (n=366) | 9.8 Score on a scale | Standard Deviation 8.44 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | General Health (n=367) | 2.3 Score on a scale | Standard Deviation 6.54 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Vitality (n=366) | 4.6 Score on a scale | Standard Deviation 8.98 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Social Functioning (n=367) | 5.0 Score on a scale | Standard Deviation 11.01 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Role-Emotional (n=367) | 3.4 Score on a scale | Standard Deviation 12.19 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Mental Health (n=367) | 2.3 Score on a scale | Standard Deviation 8.76 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Physical Component Score (n=364) | 8.2 Score on a scale | Standard Deviation 7.9 |
| ALO-02 To Placebo | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | Mental Component Score (n=364) | 1.6 Score on a scale | Standard Deviation 10.05 |
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for General Health.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Vitality.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Mental Health.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.p-value: <0.0001t-test, 2 sided
Comparison: Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.p-value: 0.0026t-test, 2 sided
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 2 (n=125,134) | -2.63 Units on a Scale | Standard Error 0.154 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 4 (n=111,123) | -2.76 Units on a Scale | Standard Error 0.172 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 8 (n=88,111) | -2.71 Units on a Scale | Standard Error 0.205 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 12/ET (n=131,137) | -2.39 Units on a Scale | Standard Error 0.176 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 12/ET (n=131,137) | -3.43 Units on a Scale | Standard Error 0.172 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 2 (n=125,134) | -3.43 Units on a Scale | Standard Error 0.15 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 8 (n=88,111) | -3.50 Units on a Scale | Standard Error 0.182 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | Week 4 (n=111,123) | -3.55 Units on a Scale | Standard Error 0.164 |
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.000295% CI: [-1.22, -0.38]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.00195% CI: [-1.25, -0.32]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.004195% CI: [-1.32, -0.25]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 12/Early Termination.p-value: <0.000195% CI: [-1.52, -0.56]ANCOVA
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 2 (n=126,134) | -2.55 Units on a Scale | Standard Error 0.162 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 4 (n=111,124) | -2.40 Units on a Scale | Standard Error 0.171 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 8 (n=89,111) | -2.44 Units on a Scale | Standard Error 0.199 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 12/ET (n=131,137) | -2.14 Units on a Scale | Standard Error 0.175 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 12/ET (n=131,137) | -3.12 Units on a Scale | Standard Error 0.171 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 2 (n=126,134) | -3.05 Units on a Scale | Standard Error 0.157 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 8 (n=89,111) | -3.21 Units on a Scale | Standard Error 0.178 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | Week 4 (n=111,124) | -3.29 Units on a Scale | Standard Error 0.162 |
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.02595% CI: [-0.95, -0.06]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.000295% CI: [-1.36, -0.43]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.003895% CI: [-1.29, -0.25]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 12/Early Termination.p-value: <0.000195% CI: [-1.46, -0.5]ANCOVA
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 2 (n=126,134) | -2.58 Units on a Scale | Standard Error 0.164 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 4 (n=111,126) | -2.52 Units on a Scale | Standard Error 0.175 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 8 (n=89,112) | -2.72 Units on a Scale | Standard Error 0.198 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 12/ET (n=131,137) | -2.24 Units on a Scale | Standard Error 0.176 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 12/ET (n=131,137) | -2.88 Units on a Scale | Standard Error 0.172 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 2 (n=126,134) | -2.99 Units on a Scale | Standard Error 0.16 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 8 (n=89,112) | -2.87 Units on a Scale | Standard Error 0.176 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Week 4 (n=111,126) | -2.99 Units on a Scale | Standard Error 0.164 |
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.072795% CI: [-0.86, 0.04]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.050195% CI: [-0.94, 0]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.570495% CI: [-0.67, 0.37]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 12/ Early Termination.p-value: 0.009695% CI: [-1.12, -0.16]ANCOVA
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 2 (n=126,134) | -3.12 Units on a Scale | Standard Error 0.17 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 4 (n=111,124) | -3.15 Units on a Scale | Standard Error 0.187 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 8 (n=88,111) | -3.00 Units on a Scale | Standard Error 0.232 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 12/ET (n=131,137) | -2.72 Units on a Scale | Standard Error 0.189 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 12/ET (n=131,137) | -3.74 Units on a Scale | Standard Error 0.186 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 2 (n=126,134) | -3.72 Units on a Scale | Standard Error 0.165 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 8 (n=88,111) | -3.71 Units on a Scale | Standard Error 0.206 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | Week 4 (n=111,124) | -3.82 Units on a Scale | Standard Error 0.177 |
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.011595% CI: [-1.06, -0.14]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.009995% CI: [-1.17, -0.16]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.022295% CI: [-1.31, -0.1]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 12/ Early Termination.p-value: 0.000195% CI: [-1.54, -0.5]ANCOVA
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 2 (n=125,134) | -2.83 Units on a Scale | Standard Error 0.157 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 4 (n=111,123) | -2.83 Units on a Scale | Standard Error 0.172 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 8 (n=88,111) | -2.80 Units on a Scale | Standard Error 0.205 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 12/ET (n=131,137) | -2.47 Units on a Scale | Standard Error 0.174 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 12/ET (n=131,137) | -3.51 Units on a Scale | Standard Error 0.171 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 2 (n=125,134) | -3.50 Units on a Scale | Standard Error 0.152 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 8 (n=88,111) | -3.53 Units on a Scale | Standard Error 0.182 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Week 4 (n=111,123) | -3.60 Units on a Scale | Standard Error 0.164 |
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.002595% CI: [-1.09, -0.24]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.001295% CI: [-1.23, -0.31]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.007895% CI: [-1.27, -0.19]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 12/Early Termination.p-value: <0.000195% CI: [-1.52, -0.56]ANCOVA
Secondary
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Time frame: Weeks 2, 4, 8 and 12
Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 2 (n=126,134) | -3.09 Units on a Scale | Standard Error 0.186 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 4 (n=111,124) | -3.01 Units on a Scale | Standard Error 0.203 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 8 (n=89,112) | -3.16 Units on a Scale | Standard Error 0.238 |
| ALO-02 To Placebo | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 12/ET (n=131,137) | -2.63 Units on a Scale | Standard Error 0.207 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 12/ET (n=131,137) | -3.73 Units on a Scale | Standard Error 0.203 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 2 (n=126,134) | -3.80 Units on a Scale | Standard Error 0.181 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 8 (n=89,112) | -3.72 Units on a Scale | Standard Error 0.212 |
| ALO-02 To ALO-02 | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | Week 4 (n=111,124) | -3.74 Units on a Scale | Standard Error 0.192 |
Comparison: Difference between treatment groups in change from Screening to Week 12/Early Termination.p-value: 0.000295% CI: [-1.67, -0.53]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 2.p-value: 0.006195% CI: [-1.22, -0.2]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 4.p-value: 0.008795% CI: [-1.28, -0.19]ANCOVA
Comparison: Difference between treatment groups in change from Screening to Week 8.p-value: 0.076995% CI: [-1.18, 0.06]ANCOVA
Secondary
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Screening (n=388) | 104.1 Dollars | Standard Deviation 605.48 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Randomization Baseline (n=343) | 88.0 Dollars | Standard Deviation 674.2 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Change from Screening (n=329) | -28.3 Dollars | Standard Deviation 548.03 |
Secondary
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital
Question 3b: nights stayed in the hospital, if answer to Q3a was yes.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital | Screening (n=9) | 0.1 Number of days | Standard Deviation 0.33 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital | Randomization Baseline (n=3) | 0.0 Number of days | Standard Deviation 0 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital | Change from Screening (n=1) | 0.0 Number of days | — |
Secondary
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Screening (n=373) | 8.8 Number of visits | Standard Deviation 33.07 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Randomization Baseline (n=325) | 5.4 Number of visits | Standard Deviation 20.58 |
| ALO-02 To Placebo | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Change from Screening (n=308) | -3.0 Number of visits | Standard Deviation 35.29 |
Secondary
Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Screening (n=264) | 84.7 Dollars | Standard Deviation 418.06 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Randomization Baseline (n=260) | 51.8 Dollars | Standard Deviation 360.94 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Change from Screening (n=248) | -41.8 Dollars | Standard Deviation 522.53 |
Secondary
Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital
Question 3b: nights stayed in the hospital, if answer to Q3a was yes.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital | Screening (n=9) | 0.1 Number of days | Standard Deviation 0.33 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital | Randomization Baseline (n=3) | 0.0 Number of days | Standard Deviation 0 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital | Change from Screening (n=1) | 0.0 Number of days | — |
Secondary
Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.
Time frame: Screening, Randomization Baseline
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Screening (n=257) | 11.4 Number of visits | Standard Deviation 38.97 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Randomization Baseline (n=247) | 5.6 Number of visits | Standard Deviation 21.84 |
| ALO-02 To Placebo | Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Change from Screening (n=234) | -4.7 Number of visits | Standard Deviation 39.19 |
Secondary
Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).
The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.
Time frame: Week 12
Population: ITT Population; imputation using last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit). | 0.50 Units on a Scale | Standard Error 0.404 |
| ALO-02 To ALO-02 | Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit). | 0.67 Units on a Scale | Standard Error 0.393 |
p-value: 0.754795% CI: [-0.94, 1.29]ANCOVA
Secondary
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time frame: Screening, Weeks 1, 2, 3, 4, 5, and 6
Population: Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Screening (n=387) | 0.6 Units on a scale | Standard Deviation 1.09 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 1 (n=353) | 0.6 Units on a scale | Standard Deviation 1.04 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 1 (n=333) | 0.0 Units on a scale | Standard Deviation 1.2 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 2 (n=327) | 0.5 Units on a scale | Standard Deviation 1.08 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 2 (n=308) | 0.0 Units on a scale | Standard Deviation 1.25 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 3 (n=316) | 0.5 Units on a scale | Standard Deviation 0.92 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 3 (n=295) | -0.1 Units on a scale | Standard Deviation 1.21 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 4 (n=210) | 0.6 Units on a scale | Standard Deviation 0.94 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 4 (n=194) | 0.0 Units on a scale | Standard Deviation 1.27 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 5 (n=138) | 0.6 Units on a scale | Standard Deviation 0.82 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 5 (n=131) | -0.1 Units on a scale | Standard Deviation 1.15 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Week 6/ET (n=375) | 0.6 Units on a scale | Standard Deviation 0.99 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from Screening at Week 6 (n=352) | 0.0 Units on a scale | Standard Deviation 1.28 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Maximum Titration Period (MTP) Value (n=375) | 1.2 Units on a scale | Standard Deviation 1.42 |
| ALO-02 To Placebo | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | Change from screening to MTP Value (n=352) | 0.6 Units on a scale | Standard Deviation 1.54 |
Secondary
COWS Total Score During the Double-Blind Treatment Period
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time frame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12
Population: Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 1 (n=111,133) | 0.3 Units on a scale | Standard Deviation 1.69 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Week 8 (n=87,107) | 0.6 Units on a scale | Standard Deviation 1.02 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 2 (n=115,128) | 0.2 Units on a scale | Standard Deviation 1.45 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 8 (n=87,107) | 0.1 Units on a scale | Standard Deviation 1.03 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Week 1 (n=111,133) | 0.8 Units on a scale | Standard Deviation 1.62 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Week 12/ET (n=126,140) | 0.7 Units on a scale | Standard Deviation 1.55 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Week 4 (n=106,123) | 0.6 Units on a scale | Standard Deviation 0.9 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 12/ET(n=126,140) | 0.2 Units on a scale | Standard Deviation 1.61 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Week 2 (n=115,128) | 0.8 Units on a scale | Standard Deviation 1.28 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Max. Double-Blind Period (DBP) Value (n=126,140) | 1.4 Units on a scale | Standard Deviation 1.84 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 4 (n=106,123) | 0.1 Units on a scale | Standard Deviation 1.1 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline to max. DBP Value (n=126,140) | 0.9 Units on a scale | Standard Deviation 1.9 |
| ALO-02 To Placebo | COWS Total Score During the Double-Blind Treatment Period | Randomization Baseline (n=134,146) | 0.6 Units on a scale | Standard Deviation 0.85 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline to max. DBP Value (n=126,140) | 0.9 Units on a scale | Standard Deviation 1.53 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Randomization Baseline (n=134,146) | 0.4 Units on a scale | Standard Deviation 0.73 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Week 1 (n=111,133) | 0.6 Units on a scale | Standard Deviation 1.13 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 1 (n=111,133) | 0.3 Units on a scale | Standard Deviation 1.12 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Week 2 (n=115,128) | 0.7 Units on a scale | Standard Deviation 1.19 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 2 (n=115,128) | 0.3 Units on a scale | Standard Deviation 1.1 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Week 4 (n=106,123) | 0.4 Units on a scale | Standard Deviation 0.66 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 4 (n=106,123) | 0.1 Units on a scale | Standard Deviation 0.79 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Week 8 (n=87,107) | 0.6 Units on a scale | Standard Deviation 1.1 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 8 (n=87,107) | 0.2 Units on a scale | Standard Deviation 1.06 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Week 12/ET (n=126,140) | 0.6 Units on a scale | Standard Deviation 1.17 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 12/ET(n=126,140) | 0.2 Units on a scale | Standard Deviation 1.21 |
| ALO-02 To ALO-02 | COWS Total Score During the Double-Blind Treatment Period | Max. Double-Blind Period (DBP) Value (n=126,140) | 1.3 Units on a scale | Standard Deviation 1.6 |
Secondary
COWS Total Score During the Post-Treatment Period
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.
Time frame: Follow-Up (FU) Weeks 1 and 2
Population: Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 1 (n=68,83) | 0.1 Units on a scale | Standard Deviation 0.9 |
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 2 (n=78,91) | -0.1 Units on a scale | Standard Deviation 1.12 |
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | FU Week 1 (n=68,83) | 0.6 Units on a scale | Standard Deviation 0.72 |
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | Max.FU Period Value (n=94,108) | 0.7 Units on a scale | Standard Deviation 0.76 |
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | Change to max. FU Period Value (n=94,108) | 0.1 Units on a scale | Standard Deviation 1.08 |
| ALO-02 To Placebo | COWS Total Score During the Post-Treatment Period | FU Week 2 (n=78,91) | 0.5 Units on a scale | Standard Deviation 0.7 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | Change to max. FU Period Value (n=94,108) | 0.7 Units on a scale | Standard Deviation 1.74 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | FU Week 1 (n=68,83) | 0.6 Units on a scale | Standard Deviation 0.91 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 1 (n=68,83) | 0.2 Units on a scale | Standard Deviation 0.99 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | FU Week 2 (n=78,91) | 0.9 Units on a scale | Standard Deviation 1.74 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 2 (n=78,91) | 0.7 Units on a scale | Standard Deviation 1.83 |
| ALO-02 To ALO-02 | COWS Total Score During the Post-Treatment Period | Max.FU Period Value (n=94,108) | 1.1 Units on a scale | Standard Deviation 1.67 |
Secondary
Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period
Time frame: Double-Blind Period
Population: Double-Blind Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period | 70.1 mg | Standard Deviation 33.67 |
| ALO-02 To ALO-02 | Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period | 63.6 mg | Standard Deviation 34.02 |
Secondary
Mean Oxycodone Average Daily Dose During the Open-Label Titration Period
Time frame: Open-Label Period
Population: Titration Period Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Mean Oxycodone Average Daily Dose During the Open-Label Titration Period | 45.8 mg | Standard Deviation 22.61 |
Secondary
Mean Oxycodone Duration of Titration During the Open-Label Titration Period
Time frame: Open-Label Period
Population: Titration Period Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Mean Oxycodone Duration of Titration During the Open-Label Titration Period | 31.0 days | Standard Deviation 12.24 |
Secondary
Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period
Time frame: Double-Blind Period
Population: Double-Blind Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period | 62.7 days | Standard Deviation 30.2 |
| ALO-02 To ALO-02 | Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period | 70.9 days | Standard Deviation 27.8 |
Secondary
Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period
Time frame: Double-Blind Period
Population: Double-Blind Safety Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALO-02 To Placebo | Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period | 60.0 mg |
| ALO-02 To ALO-02 | Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period | 59.6 mg |
Secondary
Median Oxycodone Average Daily Dose During the Open-Label Titration Period
Time frame: Open-Label Period
Population: Titration Period Safety Population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Median Oxycodone Average Daily Dose During the Open-Label Titration Period | 42.3 mg | Inter-Quartile Range 22.61 |
Secondary
Median Oxycodone Duration of Titration During the Open-Label Titration Period
Time frame: Open-Label Period
Population: Titration Period Safety Population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALO-02 To Placebo | Median Oxycodone Duration of Titration During the Open-Label Titration Period | 35.0 days | Inter-Quartile Range 12.24 |
Secondary
Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period
Time frame: Double-Blind Period
Population: Double-Blind Safety Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALO-02 To Placebo | Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period | 84.0 days |
| ALO-02 To ALO-02 | Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period | 85.0 days |
Secondary
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\].
Time frame: Screening, Week 4, 5, or 6
Population: Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Time to 20% Analgesic Response from Screening | 15 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Time to 30% Analgesic Response from Screening | 21 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Time to 40% Analgesic Response from Screening | 28 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Time to 50% Analgesic Response from Screening | 35 days |
Secondary
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\].
Time frame: Screening, Randomization Baseline (up to 6 weeks)
Population: ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Time to 20% Analgesic Response | 14 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Time to 30% Analgesic Response | 20 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Time to 40% Analgesic Response | 26 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Time to 50% Analgesic Response | 33 days |
Secondary
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period
The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\].
Time frame: Randomization Baseline, up to Week 12
Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 20% Loss of Analgesic Response | 12 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 30% Loss of Analgesic Response | 21 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 40% Loss of Analgesic Response | 41 days |
| ALO-02 To Placebo | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 50% Loss of Analgesic Response | 62 days |
| ALO-02 To ALO-02 | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 50% Loss of Analgesic Response | NA days |
| ALO-02 To ALO-02 | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 20% Loss of Analgesic Response | 31 days |
| ALO-02 To ALO-02 | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 40% Loss of Analgesic Response | NA days |
| ALO-02 To ALO-02 | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | Time to 30% Loss of Analgesic Response | NA days |
Comparison: Time to 20% loss of analgesic responsep-value: 0.0014Wilcoxon test, survival analysis
Comparison: Time to 30% loss of analgesic response.p-value: 0.0024Wilcoxon test, survival analysis
Comparison: Time to 40% loss of analgesic response.p-value: 0.0006Wilcoxon test, survival analysis
Comparison: Time to 50% loss of analgesic responsep-value: 0.0021Wilcoxon test, survival analysis
Secondary
Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period
If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the \[date of event or discontinuation - date of first dose in Double-Blind Period +1\].
Time frame: Week 1 up to Week 12
Population: ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALO-02 To Placebo | Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period | NA days |
| ALO-02 To ALO-02 | Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period | NA days |
p-value: 0.006Wilcoxon test, survival analysis
Secondary
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period
Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol
Time frame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Baseline (n=127,139) | 24.9 pg/mL | Standard Deviation 116.41 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 4 (n=3,115) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 8 (n=3,107) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 12/ET (n=4,137) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Baseline (n=127,139) | 216.0 pg/mL | Standard Deviation 800.32 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 4 (n=3,115) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 8 (n=3,107) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 12/ET (n=4,137) | 0.0 pg/mL | Standard Deviation 0 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 12/ET (n=4,137) | 55.6 pg/mL | Standard Deviation 163.41 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Baseline (n=127,139) | 5.3 pg/mL | Standard Deviation 16.48 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Baseline (n=127,139) | 97.5 pg/mL | Standard Deviation 300.17 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 4 (n=3,115) | 3.4 pg/mL | Standard Deviation 14.65 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 8 (n=3,107) | 48.3 pg/mL | Standard Deviation 156.42 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 8 (n=3,107) | 2.9 pg/mL | Standard Deviation 11.13 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | 6-β-naltrexol at Week 4 (n=3,115) | 86.1 pg/mL | Standard Deviation 315.42 |
| ALO-02 To ALO-02 | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Naltrexone at Week 12/ET (n=4,137) | 3.0 pg/mL | Standard Deviation 12.67 |
Secondary
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period
Cobs of naltrexone and 6-β-naltrexol
Time frame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
Population: Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | Naltrexone at Week 6/ET (n=77) | 4.6 pg/mL | Standard Deviation 19.02 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | Naltrexone at Randomization Baseline (n=266) | 14.6 pg/mL | Standard Deviation 81.73 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | 6-β-naltrexol at Week 6/ET (n=77) | 82.0 pg/mL | Standard Deviation 305.91 |
| ALO-02 To Placebo | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | 6-β-naltrexol at Randomization Baseline (n=266) | 154.1 pg/mL | Standard Deviation 595.8 |
Secondary
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period
Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone
Time frame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Baseline (n=127,140) | 27.0 ng/mL | Standard Deviation 29.06 |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 4 (n=0,116) | NA ng/mL | — |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 8 (n=0,107) | NA ng/mL | — |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 12/ET (n=1,137) | 0.0 ng/mL | — |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Baseline (n=127,140) | 33.1 ng/mL | Standard Deviation 48.84 |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 4 (n=0,116) | NA ng/mL | — |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 8 (n=0,107) | NA ng/mL | — |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 12/ET (n=1,137) | 0.0 ng/mL | — |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 12/ET (n=1,137) | 26.3 ng/mL | Standard Deviation 40.67 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Baseline (n=127,140) | 25.9 ng/mL | Standard Deviation 28.73 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Baseline (n=127,140) | 27.1 ng/mL | Standard Deviation 34.67 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 4 (n=0,116) | 23.3 ng/mL | Standard Deviation 26.9 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 8 (n=0,107) | 26.2 ng/mL | Standard Deviation 34.38 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 8 (n=0,107) | 23.1 ng/mL | Standard Deviation 23.83 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Noroxycodone at Week 4 (n=0,116) | 25.5 ng/mL | Standard Deviation 40.54 |
| ALO-02 To ALO-02 | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Oxycodone at Week 12/ET (n=1,137) | 22.6 ng/mL | Standard Deviation 26.98 |
Secondary
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period
Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.
Time frame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
Population: Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Oxycodone at Week 6/ET (n=77) | 14.1 ng/mL | Standard Deviation 22.27 |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Oxycodone at Randomization Baseline (n=267) | 26.4 ng/mL | Standard Deviation 28.84 |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Noroxycodone at Week 6/ET (n=77) | 15.5 ng/mL | Standard Deviation 26.5 |
| ALO-02 To Placebo | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Noroxycodone at Randomization Baseline (n=267) | 29.9 ng/mL | Standard Deviation 42.04 |
Secondary
Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy
If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.
Time frame: Week 1 up to Week 12
Population: ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-02 To Placebo | Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy | 11.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy | 2.7 Percentage of participants |
Secondary
Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period
Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).
Time frame: Week 12 or Early Termination
Population: ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | Yes (n=125,128) | 59.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | No (n=125,128) | 40.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | Yes (n=125,128) | 79.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | No (n=125,128) | 20.3 Percentage of participants |
p-value: 0.0004Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.
Time frame: Screening, Week 4, 5 or 6
Population: Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Participants with 40% Analgesic Response | 67.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Participants with 20% Analgesic Response | 85.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Participants with 30% Analgesic Response | 78.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | Participants with 50% Analgesic Response | 49.7 Percentage of participants |
Secondary
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.
Time frame: Screening, Randomization Baseline (up to 6 weeks)
Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Participants with 20% Analgesic Response | 99.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Participants with 30% Analgesic Response | 95.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Participants with 40% Analgesic Response | 86.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | Participants with 50% Analgesic Response | 64.0 Percentage of participants |
Secondary
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period
The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\].
Time frame: Randomization Baseline, up to Week 12
Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 20% Loss of Analgesic Response | 72.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 30% Loss of Analgesic Response | 64.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 40% Loss of Analgesic Response | 57.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 50% Loss of Analgesic Response | 50.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 50% Loss of Analgesic Response | 31.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 20% Loss of Analgesic Response | 54.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 40% Loss of Analgesic Response | 34.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | Participants with 30% Loss of Analgesic Response | 46.2 Percentage of participants |
Secondary
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%
Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time frame: Weeks 11 and 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30% | 44.0 percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30% | 57.5 percentage of participants |
p-value: 0.0248Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%
Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time frame: Weeks 11 and 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40% | 35.1 percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40% | 50.7 percentage of participants |
p-value: 0.009Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%
Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time frame: Weeks 11 and 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50% | 29.9 percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50% | 39.7 percentage of participants |
p-value: 0.0874Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%
Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.
Time frame: Weeks 11 and 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20% | 48.5 percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20% | 62.3 percentage of participants |
p-value: 0.021Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time frame: Follow-Up Weeks 1 and 2
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 2 COWS <5 (n=78,91) | 100 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | Maximum FU Period COWS <5 (n=94,108) | 100.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 2 COWS=5-12 (n=78,91) | 0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | Maximum FU Period COWS=5-12 (n=94,108) | 0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 1 COWS <5 (n=68,83) | 100.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | Maximum FU Period COWS=5-12 (n=94,108) | 3.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 1 COWS <5 (n=68,83) | 100.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 2 COWS <5 (n=78,91) | 95.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | FU Week 2 COWS=5-12 (n=78,91) | 4.4 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | Maximum FU Period COWS <5 (n=94,108) | 96.3 Percentage of participants |
Secondary
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time frame: Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Randomization Baseline COWS <5 (n=134,146) | 100 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS <5 (n=111,133) | 99.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS 5-12 (n=111,133) | 0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS 13-24 (n=111,133) | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 2 COWS <5 (n=115,128) | 99.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 2 COWS 5-12 (n=115,128) | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 4 COWS <5 (n=106,123) | 99.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 4 COWS 5-12 (n=106,123) | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 8 COWS <5 (n=87,107) | 100 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 8 COWS 5-12 (n=87,107) | 0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS <5 (n=126,140) | 98.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS 5-12 (n=126,140) | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS 13-24 (n=126,140) | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS <5 (n=126,140) | 97.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS 5-12 (n=126,140) | 1.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS 13-24 (n=126,140) | 0.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS 13-24 (n=126,140) | 0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Randomization Baseline COWS <5 (n=134,146) | 100 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 8 COWS <5 (n=87,107) | 98.1 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS <5 (n=111,133) | 98.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS 13-24 (n=126,140) | 0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS 5-12 (n=111,133) | 1.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 8 COWS 5-12 (n=87,107) | 1.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 1 COWS 13-24 (n=111,133) | 0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS 5-12 (n=126,140) | 5.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 2 COWS <5 (n=115,128) | 98.4 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS <5 (n=126,140) | 97.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 2 COWS 5-12 (n=115,128) | 1.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Max. DBP Value COWS <5 (n=126,140) | 95.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 4 COWS <5 (n=106,123) | 100 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 12/ET COWS 5-12 (n=126,140) | 2.1 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | Week 4 COWS 5-12 (n=106,123) | 0 Percentage of participants |
Secondary
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category
The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time frame: Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Screening COWS less than(<)5 (n=387) | 98.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Screening COWS=5-12 (n=387) | 1.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 1 COWS <5 (n=353) | 99.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 1 COWS=5-12 (n=353) | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 2 COWS <5 (n=327) | 98.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 2 COWS 5-12 (n=327) | 1.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 3 COWS <5 (n=316) | 99.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 3 COWS 5-12 (n=316) | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 4 COWS <5 (n=210) | 99.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 4 COWS 5-12 (n=210) | 0.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 5 COWS <5 (n=138) | 100 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 6 COWS <5 (n=375) | 98.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Week 6 COWS 5-12 (n=375) | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Max. Titration Period Value COWS <5 (n=375) | 96.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | Max. Titration Period Value COWS 5-12 (n=375) | 3.2 Percentage of participants |
Secondary
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor
Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time frame: Randomization Baseline, Week 4
Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Fair | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Poor | 1.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Fair | 7.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Good | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Good | 2.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Good | 3.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Fair | 2.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Good | 5.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Good | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Good | 15.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Good | 24.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Poor | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Fair | 24.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Good | 7.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Good | 8.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Good | 0.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Fair | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Good | 6.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Good | 27.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Fair | 13.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Good | 1.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Good | 15.1 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Fair | 23.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Poor | 2.4 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Poor | 0.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Poor | 0.0 Percentage of participants |
p-value: 0.2211Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor
Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time frame: Randomization Baseline, Week 8
Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Fair | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Poor | 2.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Fair | 12.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Good | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Good | 5.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Fair | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Very Good | 5.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Very Good | 3.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Good | 14.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Fair | 2.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Good | 25.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Poor | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Fair | 17.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Very Good | 8.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Very Good | 8.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Good | 3.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Fair | 1.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Very Good | 8.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Good | 23.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Fair | 11.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Poor | 0.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Very Good | 0.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Good | 15.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Fair | 21.4 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Poor | 1.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Fair | 0.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Poor | 0.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Good | 0.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Very Poor / Poor | 0.0 Percentage of participants |
p-value: 0.5767Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time frame: Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)
Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 4 (n=108, 123) | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 4 (n=108, 123) | 3.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 4 (n=108, 123) | 1.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 4 (n=108, 123) | 94.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 8 (n=85, 110) | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 8 (n=85, 110) | 1.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 8 (n=85, 110) | 2.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 8 (n=85, 110) | 96.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week12/ET (n=129, 134) | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week12/ET (n=129, 134) | 3.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week12/ET (n=129, 134) | 1.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 12/ET (n=129, 134) | 95.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week12/ET (n=129, 134) | 0.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 4 (n=108, 123) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 8 (n=85, 110) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 4 (n=108, 123) | 0.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week12/ET (n=129, 134) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 4 (n=108, 123) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 8 (n=85, 110) | 99.1 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 4 (n=108, 123) | 99.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 12/ET (n=129, 134) | 99.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 8 (n=85, 110) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week12/ET (n=129, 134) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 8 (n=85, 110) | 0.9 Percentage of participants |
Secondary
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire
Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time frame: Screening, Week 6 (or Early Termination)
Population: Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | Yes/Yes | 0.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | Yes/No | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | No/Yes | 2.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | No/No | 96.4 Percentage of participants |
Secondary
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time frame: Screening, Randomization Baseline
Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes | 0.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes | 2.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No | 95.6 Percentage of participants |
Secondary
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?
Time frame: Screening, Weeks 4, 8, and 12
Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 4 (n=109,124) | 0.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 4 (n=109,124) | 2.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 4 (n=109,124) | 2.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 4 (n=109,124) | 93.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 8 (n=86,111) | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 8 (n=86, 111) | 1.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 8 (n=86, 111) | 2.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 8 (n=86, 111) | 96.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 12/ET (n=130,136) | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 12/ET (n=130,136) | 2.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 12/ET (n=130,136) | 3.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 12/ET (n=130,136) | 93.1 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 12/ET (n=130,136) | 2.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 4 (n=109,124) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 8 (n=86, 111) | 1.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 4 (n=109,124) | 0.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 12/ET (n=130,136) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/Yes Week 4 (n=109,124) | 1.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 8 (n=86, 111) | 97.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 4 (n=109,124) | 97.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | No/No Week 12/ET (n=130,136) | 97.8 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 8 (n=86,111) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/Yes Week 12/ET (n=130,136) | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Yes/No Week 8 (n=86, 111) | 0.9 Percentage of participants |
Secondary
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time frame: Screening, Randomization Baseline
Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Poor | 0.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Good | 0.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Good | 2.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Fair | 9.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Poor | 2.9 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Good | 5.8 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Fair | 29.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Poor | 8.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Poor | 1.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Good | 2.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Fair | 22.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Poor | 10.5 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Poor | 1.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Good | 0.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Fair | 2.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.0 Percentage of participants |
p-value: <0.0001Bowker's test of symmetry
Secondary
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.
Time frame: Screening, Randomization Baseline, or Early Termination
Population: Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Good | 0.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Good | 2.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Fair | 7.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Poor | 2.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Good | 5.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Fair | 25.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Poor | 7.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Good / Very Poor | 1.1 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Good | 2.7 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Fair | 27.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Poor | 10.6 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Fair / Very Poor | 1.4 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Good | 0.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Fair | 3.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Poor | 2.2 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Poor / Very Poor | 0.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Poor | 0.3 Percentage of participants |
| ALO-02 To Placebo | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Very Poor / Very Poor | 0.3 Percentage of participants |
p-value: <0.0001Bowker's test of symmetry
Secondary
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).
Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).
Time frame: Randomization Baseline, Week 12
Population: ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Fair | 1.5 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Poor | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Fair | 4.6 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Very Good | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Good | 2.3 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Good | 6.2 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Fair | 4.6 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Poor | 1.5 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Very Good | 6.2 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Very Good | 3.1 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Poor | 0.8 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Good | 1.5 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Good | 17.7 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Fair | 1.5 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Good | 18.5 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Fair | 23.1 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To Placebo | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Very Good | 5.4 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Very Good | 11.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Good | 2.9 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Fair | 1.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Very Good | 3.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Good | 19.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Fair | 6.6 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Poor | 0.7 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Good / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Good | 21.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Fair | 26.3 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Poor | 2.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Fair / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Good | 1.5 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Fair | 2.2 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Poor / Very Poor | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Very Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Good | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Fair | 0.0 Percentage of participants |
| ALO-02 To ALO-02 | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Very Poor / Poor | 0.0 Percentage of participants |
p-value: 0.1272Cochran-Mantel-Haenszel
Secondary
Satisfaction With Treatment at Randomization Baseline
Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.
Time frame: Randomization Baseline
Population: ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Satisfaction With Treatment at Randomization Baseline | Very Dissatisfied (n=278) | 5.4 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at Randomization Baseline | Dissatisfied (n=278) | 2.2 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at Randomization Baseline | Neither Satisfied or Dissatisfied (n=278) | 4.7 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at Randomization Baseline | Satisfied (n=278) | 46.0 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at Randomization Baseline | Very Satisfied (n=278) | 41.7 Percentage of participants |
Secondary
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants
Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.
Time frame: End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)
Population: Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALO-02 To Placebo | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Very Dissatisfied (n=369) | 6.8 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Dissatisfied (n=369) | 7.0 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Neither Satisfied or Dissatisfied (n=369) | 11.7 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Satisfied (n=369) | 40.7 Percentage of participants |
| ALO-02 To Placebo | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Very Satisfied (n=369) | 33.9 Percentage of participants |
Secondary
SOWS Total Score During the Double-Blind Treatment Period
The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time frame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Randomization Baseline (n=134,146) | 2.4 Units on a scale | Standard Deviation 3.88 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Week 1 (n=134,143) | 3.0 Units on a scale | Standard Deviation 4.27 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 1 (n=134,143) | 0.6 Units on a scale | Standard Deviation 4.08 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Week 2 (n=123,135) | 3.5 Units on a scale | Standard Deviation 6.56 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 2 (n=123,135) | 1.1 Units on a scale | Standard Deviation 5.37 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Max. SOWS, First 2 Weeks of Period (n=134,143) | 6.3 Units on a scale | Standard Deviation 7.72 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Week 4 (n=105,122) | 2.5 Units on a scale | Standard Deviation 3.91 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 4 (n=105,122) | 0.1 Units on a scale | Standard Deviation 3.57 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Week 8 (n=85,110) | 2.4 Units on a scale | Standard Deviation 4.48 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 8 (n=85,110) | 0.1 Units on a scale | Standard Deviation 3.83 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Week 12 (n=134,143) | 3.3 Units on a scale | Standard Deviation 5.7 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 12 (n=134,143) | 0.9 Units on a scale | Standard Deviation 5.11 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Max. SOWS (Double-Blind Period) (n=134,143) | 6.7 Units on a scale | Standard Deviation 7.77 |
| ALO-02 To Placebo | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at max. SOWs (n=134,143) | 4.3 Units on a scale | Standard Deviation 5.82 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Week 12 (n=134,143) | 2.4 Units on a scale | Standard Deviation 3.85 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Randomization Baseline (n=134,146) | 1.5 Units on a scale | Standard Deviation 2.2 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 4 (n=105,122) | 0.5 Units on a scale | Standard Deviation 2.39 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Week 1 (n=134,143) | 2.3 Units on a scale | Standard Deviation 3.69 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Max. SOWS (Double-Blind Period) (n=134,143) | 5.2 Units on a scale | Standard Deviation 5.89 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 1 (n=134,143) | 0.8 Units on a scale | Standard Deviation 2.93 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Week 8 (n=85,110) | 2.1 Units on a scale | Standard Deviation 3.37 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Week 2 (n=123,135) | 1.9 Units on a scale | Standard Deviation 3.11 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 12 (n=134,143) | 0.9 Units on a scale | Standard Deviation 3.01 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 2 (n=123,135) | 0.3 Units on a scale | Standard Deviation 2.64 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at Week 8 (n=85,110) | 0.6 Units on a scale | Standard Deviation 2.92 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Max. SOWS, First 2 Weeks of Period (n=134,143) | 4.4 Units on a scale | Standard Deviation 5.11 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Change from Baseline at max. SOWs (n=134,143) | 3.7 Units on a scale | Standard Deviation 5.14 |
| ALO-02 To ALO-02 | SOWS Total Score During the Double-Blind Treatment Period | Week 4 (n=105,122) | 2.1 Units on a scale | Standard Deviation 3.42 |
Secondary
SOWS Total Score During the Post-Treatment Period
The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time frame: Follow-Up Weeks 1 and 2
Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | FU Week 1 (n=94,108) | 2.6 Units on a scale | Standard Deviation 4.91 |
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 1 (n=94,108) | 0.2 Units on a scale | Standard Deviation 4.12 |
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | FU Week 2 (n=95,109) | 2.7 Units on a scale | Standard Deviation 5.26 |
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 2 (n=95,109) | 0.2 Units on a scale | Standard Deviation 4.49 |
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | Max. SOWS (FU Period)(n=96,110) | 4.7 Units on a scale | Standard Deviation 6.73 |
| ALO-02 To Placebo | SOWS Total Score During the Post-Treatment Period | Change from Baseline at Max. SOWS, (n=96,110) | 2.2 Units on a scale | Standard Deviation 5.31 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | Max. SOWS (FU Period)(n=96,110) | 4.5 Units on a scale | Standard Deviation 5.45 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | FU Week 1 (n=94,108) | 2.3 Units on a scale | Standard Deviation 3.69 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 2 (n=95,109) | 1.0 Units on a scale | Standard Deviation 3.35 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | Change from Baseline at FU Week 1 (n=94,108) | 0.8 Units on a scale | Standard Deviation 3.21 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | Change from Baseline at Max. SOWS, (n=96,110) | 3.0 Units on a scale | Standard Deviation 4.77 |
| ALO-02 To ALO-02 | SOWS Total Score During the Post-Treatment Period | FU Week 2 (n=95,109) | 2.5 Units on a scale | Standard Deviation 3.67 |
Secondary
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period
The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.
Time frame: Screening, Weeks 1, 2, 3, 4, 5, and 6
Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Screening (n=395) | 4.1 Units on a scale | Standard Deviation 4.92 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 1 (n=355) | 3.5 Units on a scale | Standard Deviation 4.31 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 1 (n=346) | -0.7 Units on a scale | Standard Deviation 4.71 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 2 (n=329) | 3.0 Units on a scale | Standard Deviation 3.66 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 2 (n=320) | -1.2 Units on a scale | Standard Deviation 4.64 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 3 (n=311) | 2.7 Units on a scale | Standard Deviation 4.17 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 3 (n=304) | -1.4 Units on a scale | Standard Deviation 5.24 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 4 (n=206) | 2.2 Units on a scale | Standard Deviation 2.92 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 4 (n=199) | -2.1 Units on a scale | Standard Deviation 4.92 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 5 (n=139) | 2.2 Units on a scale | Standard Deviation 2.96 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 5 (n=133) | -2.4 Units on a scale | Standard Deviation 4.42 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Week 6/ET (n=369) | 3.0 Units on a scale | Standard Deviation 4.41 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Week 6/ET (n=359) | -1.2 Units on a scale | Standard Deviation 5.36 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Max. SOWS (Titration Period) (n=369) | 4.9 Units on a scale | Standard Deviation 5.35 |
| ALO-02 To Placebo | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | Change from Screening at Max. SOWS (n=359) | 0.7 Units on a scale | Standard Deviation 5.51 |