Chronic Pain
Conditions
Keywords
osteoarthritis, low back pain, Moderate to Severe Pain
Brief summary
The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.
Detailed description
The study consisted of a screening period of approximately 7 to 14 days, an open label titration period of up to 6 weeks, and a double blind treatment period of 12 weeks. Participants entered the open label titration period and received hydrocodone ER tablets beginning with 15 mg every 12 hours for 3 to 7 days. The objective of the open label titration period was to find the successful dose of hydrocodone ER tablets that produced stable pain relief (defined as an Average Pain Intensity (API) score of 4 or less on the 11-point numerical rating scale for either 3 consecutive days or 3 out of 5 consecutive days while the patient was maintained on the same dose of study drug for up to 7 days). Patients returned to the study center prior to each dose adjustment. Participants who met the criterion of a stabilized dose were randomly assigned into the 12 week, double blind, placebo controlled treatment period on the final day of the open label titration period (baseline visit). Patients began treatment with double blind study drug at the effective dose of hydrocodone ER tablets achieved during the titration period or matching placebo. Rescue medication was permitted in addition to the study drug during the double blind treatment period.
Interventions
DRUGHydrocodone ER
During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain. Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period. Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.
DRUGPlacebo
Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period. Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient is able to speak English and is willing to provide written informed consent, including a written opioid agreement, to participate in this study. * The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol. * Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening. * The patient has pain of at least 3 months' duration associated with osteoarthritis or low back pain. * The patient reports an average pain intensity score, over the prior 24 hours, of 5 or more on the 11-point numerical rating scale. * If the patient is receiving physical therapy, biofeedback therapy, acupuncture therapy, or herbal remedies, these therapies must remain unchanged during the study. * The patient must not participate in other study involving an investigational agent while enrolled into the present study.
Exclusion criteria
* The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. * The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse with the exception of nicotine or caffeine. * The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. * The patient is taking a total (ie, around-the-clock plus rescue medication) of more than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening. * The patient has a history of suicidality. * The patient is expected to have surgery during the study. * The patient's primary painful condition under study is related to any source of chronic pain other than osteoarthritis or low back pain. * The patient is pregnant or lactating. * The patient has active malignancy. * The patient has human immunodeficiency virus (HIV). * In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values. * The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with opioids. * The patient has participated in a study involving an investigational drug in the previous 30 days. * The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. * The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. * The patient is involved in active litigation in regard to the pain currently being treated. * The patient has a positive urine drug screen (UDS) that is not medically explainable. * The investigator feels that the patient is not suitable for the study for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI) | Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period | The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimates for Time to Discontinuation From the Study | Day 1 to Week 12 of the double-blind treatment period | Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment. |
| Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period | The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. |
| Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period | The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. |
| Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period | The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. |
| Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period | The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. |
| Clinician Assessment of Patient Function (CAPF) at Week 4 | Week 4 of the Double-blind Treatment Period | Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. |
| Clinician Assessment of Patient Function (CAPF) at Week 8 | Week 8 of the Double-blind Treatment Period | Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. |
| Clinician Assessment of Patient Function (CAPF) at Week 12 | Week 12 of the Double-blind Treatment Period | Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. |
| Clinician Assessment of Patient Function (CAPF) at Endpoint | Endpoint of the Double-blind Treatment Period (up to week 12) | Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. Endpoint values are the last observed postbaseline data. |
| Patient Assessment of Function (PAF) at Week 4 | Week 4 of the Double-blind Treatment Period | The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life |
| Patient Assessment of Function (PAF) at Week 8 | Week 8 of the Double-blind Treatment Period | The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life |
| Patient Assessment of Function (PAF) at Week 12 | Week 12 of the Double-blind Treatment Period | The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life |
| Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Day 1 to Week 12 of the double-blind treatment period | Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy. |
| Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period | The CGI-S is a clinician-rated scale that assesses the severity of the patient's pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories: * 1 normal-shows no sign of illness, * 2 borderline ill, * 3 mildly (slightly) ill, * 4 moderately ill, * 5 markedly ill, * 6 severely ill, and * 7 among the most extremely ill (Guy 1976). The clinician assesses the severity of the patient's condition, based on the clinician's total clinical experience with patients with this condition, in response to treatment. Endpoint values are the last observed postbaseline data. |
| Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period | SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. |
| Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period | For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 \[does not interfere\] to 10 \[completely interferes\]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration. |
| Participants With Adverse Events | Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period | An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. |
| Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Day 1 up to Day 128 in Double-Blind Treatment period | Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg |
| Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Day 1 up to Day 128 in Double-Blind Treatment period | Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Uric acid: M\>=625, F\>=506 μmol/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 % * Urinalysis: blood (hemoglobin) and total protein: \>=2 unit increase from baseline |
| Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period | The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit. |
| Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period | The COWS was a clinician rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: * 0 to 4=normal * 5 to 12=mild * 13 to 24=moderate * 25 to 36=moderately severe * \>36=severe |
| Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period | The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination. |
| Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period | The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior. The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination. |
| Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period | A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination). |
| Patient Assessment of Function (PAF) at Endpoint | Endpoint of the Double-blind Treatment Period (up to week 12) | The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life Endpoint values are the last observed postbaseline data. |
Countries
United States
Participant flow
Recruitment details
A total of 519 patients with osteoarthritis or low back pain were screened for enrollment into the study; of these, 391 patients at 71 centers in the US met entry criteria and were enrolled into the titration period of the study.
Pre-assignment details
Of the 389 patients enrolled and treated during the titration period, 294 (75%) patients identified a successful dose and therefore completed the open-label titration period, and were randomly assigned to receive hydrocodone extended-release (ER) tablets (146 patients) or placebo (148 patients) in the double-blind treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Double-blind Treatment Period) Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo. | 148 |
| Hydrocodone ER (Double-blind Treatment Period) Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period. | 146 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Treatment Period (12 Weeks) | Adverse Event | 0 | 4 | 10 |
| Double-blind Treatment Period (12 Weeks) | Lack of Efficacy | 0 | 17 | 5 |
| Double-blind Treatment Period (12 Weeks) | Noncompliance to study drug admin | 0 | 9 | 11 |
| Double-blind Treatment Period (12 Weeks) | Noncompliance to study procedures | 0 | 2 | 2 |
| Double-blind Treatment Period (12 Weeks) | Other | 0 | 1 | 5 |
| Double-blind Treatment Period (12 Weeks) | Physician Decision | 0 | 1 | 0 |
| Double-blind Treatment Period (12 Weeks) | Protocol Violation | 0 | 9 | 14 |
| Double-blind Treatment Period (12 Weeks) | Withdrawal by Subject | 0 | 3 | 5 |
| Open-label Titration Period | Adverse Event | 47 | 0 | 0 |
| Open-label Titration Period | Dropped out prior to dosing | 2 | 0 | 0 |
| Open-label Titration Period | Lack of Efficacy | 19 | 0 | 0 |
| Open-label Titration Period | Noncompliance to study drug admin | 3 | 0 | 0 |
| Open-label Titration Period | Noncompliance to study procedures | 3 | 0 | 0 |
| Open-label Titration Period | Other | 7 | 0 | 0 |
| Open-label Titration Period | Protocol Violation | 7 | 0 | 0 |
| Open-label Titration Period | Withdrawal by Subject | 9 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo (Double-blind Treatment Period) | Total | Hydrocodone ER (Double-blind Treatment Period) |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 12.09 | 53.1 years STANDARD_DEVIATION 11.26 | 53.6 years STANDARD_DEVIATION 10.38 |
| Age group <=65 years | 133 Participants | 259 Participants | 126 Participants |
| Age group >65 years | 15 Participants | 35 Participants | 20 Participants |
| Body Mass Index | 32.8 kg/m^2 STANDARD_DEVIATION 7.33 | 32.9 kg/m^2 STANDARD_DEVIATION 7.74 | 33.0 kg/m^2 STANDARD_DEVIATION 8.16 |
| Duration of Opioid Therapy | 4.1 years STANDARD_DEVIATION 4.9 | 4.0 years STANDARD_DEVIATION 4.82 | 3.9 years STANDARD_DEVIATION 4.76 |
| Duration since Diagnosis | 12.5 years STANDARD_DEVIATION 9.06 | 12.3 years STANDARD_DEVIATION 9.51 | 12.1 years STANDARD_DEVIATION 9.97 |
| Participants on Opioid Therapy Not on opioid therapy | 45 Participants | 91 Participants | 46 Participants |
| Participants on Opioid Therapy On opioid therapy | 103 Participants | 203 Participants | 100 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 41 Participants | 69 Participants | 28 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 12 Participants | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic and non-Latino | 144 Participants | 281 Participants | 137 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 105 Participants | 220 Participants | 115 Participants |
| Sex: Female, Male Female | 88 Participants | 175 Participants | 87 Participants |
| Sex: Female, Male Male | 60 Participants | 119 Participants | 59 Participants |
| Type of Pain Low back pain | 107 Participants | 211 Participants | 104 Participants |
| Type of Pain Osteoarthritis | 41 Participants | 83 Participants | 42 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 | 167 / 389 | 24 / 147 | 45 / 146 |
| serious Total, serious adverse events | 2 / 389 | 3 / 147 | 3 / 146 |
Outcome results
Primary
Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)
The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity.
Time frame: Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period
Population: Full analysis set (FAS). One placebo patient was withdrawn from the study prior to receiving drug in the Double-blind Treatment period and is not included in the FAS. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI) | 0.14 units on a scale | Standard Error 0.169 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI) | -0.22 units on a scale | Standard Error 0.176 |
p-value: 0.13495% CI: [-0.11, 0.82]ANCOVA
Secondary
Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.
Time frame: Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Double-blind Treatment | 0.1 units on a scale | Standard Deviation 0.39 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 8 | 0.1 units on a scale | Standard Deviation 0.36 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Open-Label Titration | 0.3 units on a scale | Standard Deviation 0.65 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 12 | 0.1 units on a scale | Standard Deviation 0.38 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 1 | 0.2 units on a scale | Standard Deviation 0.47 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Endpoint | 0.3 units on a scale | Standard Deviation 0.75 |
| Placebo (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 4 | 0.1 units on a scale | Standard Deviation 0.4 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Endpoint | 0.3 units on a scale | Standard Deviation 0.73 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Open-Label Titration | 0.3 units on a scale | Standard Deviation 0.7 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Double-blind Treatment | 0.2 units on a scale | Standard Deviation 0.43 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 4 | 0.3 units on a scale | Standard Deviation 0.7 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 8 | 0.2 units on a scale | Standard Deviation 0.47 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 12 | 0.1 units on a scale | Standard Deviation 0.38 |
| Hydrocodone ER (Double-blind Treatment Period) | Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 1 | 0.2 units on a scale | Standard Deviation 0.5 |
Secondary
Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period
For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 \[does not interfere\] to 10 \[completely interferes\]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 2 | 2.9 units on a scale | Standard Deviation 2.25 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 8 | 2.9 units on a scale | Standard Deviation 2.37 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 1 | 3.0 units on a scale | Standard Deviation 2.23 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 12 | 3.0 units on a scale | Standard Deviation 2.31 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 4 | 2.9 units on a scale | Standard Deviation 2.39 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Endpoint | 3.5 units on a scale | Standard Deviation 2.45 |
| Placebo (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Baseline | 2.9 units on a scale | Standard Deviation 2.09 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Endpoint | 3.3 units on a scale | Standard Deviation 2.28 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Baseline | 2.8 units on a scale | Standard Deviation 2.05 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 1 | 3.1 units on a scale | Standard Deviation 2.22 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 2 | 2.7 units on a scale | Standard Deviation 2.19 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 4 | 2.8 units on a scale | Standard Deviation 2.06 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 8 | 2.9 units on a scale | Standard Deviation 2.23 |
| Hydrocodone ER (Double-blind Treatment Period) | Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period | Week 12 | 3.3 units on a scale | Standard Deviation 2.3 |
Secondary
Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters
A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).
Time frame: Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period
Population: FAS of participants contributing baseline and endpoint data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QRS interval | -0.1 msec | Standard Deviation 15.96 |
| Placebo (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QTc interval (Bazett) | -1.0 msec | Standard Deviation 20.34 |
| Placebo (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QT interval | -3.1 msec | Standard Deviation 27.08 |
| Placebo (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QTc interval (Fridericia) | -2.5 msec | Standard Deviation 21.1 |
| Placebo (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | PR interval | -1.8 msec | Standard Deviation 16.27 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QTc interval (Fridericia) | 2.9 msec | Standard Deviation 21.7 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | PR interval | -2.4 msec | Standard Deviation 29.3 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QRS interval | 0.6 msec | Standard Deviation 10.43 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QT interval | 2.2 msec | Standard Deviation 28.28 |
| Hydrocodone ER (Double-blind Treatment Period) | Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters | QTc interval (Bazett) | 4.2 msec | Standard Deviation 22.74 |
Secondary
Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period
The COWS was a clinician rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: * 0 to 4=normal * 5 to 12=mild * 13 to 24=moderate * 25 to 36=moderately severe * \>36=severe
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 2 | 0.7 units on a scale | Standard Deviation 1.33 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Baseline | 0.5 units on a scale | Standard Deviation 0.9 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 8 | 0.7 units on a scale | Standard Deviation 1.34 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 4 | 0.8 units on a scale | Standard Deviation 1.58 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 12 | 0.5 units on a scale | Standard Deviation 0.92 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 1 | 0.8 units on a scale | Standard Deviation 1.51 |
| Placebo (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Endpoint | 0.7 units on a scale | Standard Deviation 1.13 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Endpoint | 1.1 units on a scale | Standard Deviation 2.02 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Baseline | 0.5 units on a scale | Standard Deviation 0.9 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 1 | 0.7 units on a scale | Standard Deviation 1.29 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 4 | 0.6 units on a scale | Standard Deviation 1.22 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 8 | 0.6 units on a scale | Standard Deviation 1.15 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 12 | 0.8 units on a scale | Standard Deviation 1.76 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period | Week 2 | 0.5 units on a scale | Standard Deviation 0.92 |
Secondary
Clinician Assessment of Patient Function (CAPF) at Endpoint
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study. Endpoint values are the last observed postbaseline data.
Time frame: Endpoint of the Double-blind Treatment Period (up to week 12)
Population: FAS of participants with assessments at the timeframe
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Slightly improved | 33 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Much improved | 24 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Much improved | 24 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Unchanged | 59 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Very much improved | 10 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Unchanged | 46 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Slightly improved | 34 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Very much improved | 11 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Slightly worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Unchanged | 90 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Slightly worsened | 9 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Slightly improved | 15 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Much improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Slightly improved | 36 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Much worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Slightly worsened | 9 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Unchanged | 66 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Slightly improved | 20 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Much worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Much improved | 25 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Unchanged | 49 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Very much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Much worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Unchanged | 38 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Slightly improved | 37 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Much improved | 40 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | General Activities: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Slightly worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Unchanged | 45 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Slightly improved | 32 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Much improved | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Walking ability: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Much worsened | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Unchanged | 46 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Slightly improved | 33 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Much improved | 36 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Daily living: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Unchanged | 78 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Much improved | 15 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Relationships: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Much worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Slightly worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Unchanged | 57 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Slightly improved | 31 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Endpoint | Enjoyment: Much improved | 27 Participants |
Secondary
Clinician Assessment of Patient Function (CAPF) at Week 12
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Time frame: Week 12 of the Double-blind Treatment Period
Population: FAS of participants with assessments at the timeframe
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Slightly worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Slightly improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Slightly worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Much improved | 20 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Unchanged | 38 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Very much improved | 10 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Much improved | 19 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Slightly improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Slightly worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Much improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Unchanged | 59 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Unchanged | 29 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Slightly improved | 13 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Much improved | 15 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Slightly worsened | 5 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Unchanged | 42 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Slightly worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Slightly improved | 16 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Slightly improved | 29 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Unchanged | 30 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Very much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Very much improved | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Much worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Unchanged | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Slightly improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Much improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | General Activities: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Unchanged | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Slightly improved | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Much improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Walking ability: Very much improved | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Much worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Unchanged | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Slightly improved | 22 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Much improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Daily living: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Unchanged | 47 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Slightly improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Much improved | 14 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Relationships: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Unchanged | 31 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Slightly improved | 23 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 12 | Enjoyment: Much improved | 21 Participants |
Secondary
Clinician Assessment of Patient Function (CAPF) at Week 4
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Time frame: Week 4 of the Double-blind Treatment Period
Population: FAS of participants with assessments at the timeframe
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Slightly improved | 32 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Much improved | 31 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Much improved | 29 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Unchanged | 35 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Unchanged | 31 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Slightly improved | 36 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Slightly worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Much improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Unchanged | 72 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Slightly improved | 13 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Very much improved | 5 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Much improved | 16 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Slightly improved | 33 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Unchanged | 48 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Slightly worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Slightly improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Much improved | 19 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Unchanged | 36 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Very much improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Unchanged | 23 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Slightly improved | 38 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Much improved | 29 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | General Activities: Very much improved | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Unchanged | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Slightly improved | 36 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Much improved | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Walking ability: Very much improved | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Unchanged | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Slightly improved | 39 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Much improved | 29 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Daily living: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Unchanged | 60 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Slightly improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Much improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Relationships: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Unchanged | 39 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 4 | Enjoyment: Much improved | 28 Participants |
Secondary
Clinician Assessment of Patient Function (CAPF) at Week 8
Clinicians assessed participants across 5 dimensions: * Patients general activities * Patients walking ability * Patients ability to work/perform activities of daily living * Patients relationships with others * Patients enjoyment of life Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.
Time frame: Week 8 of the Double-blind Treatment Period
Population: FAS of participants with assessments at the timeframe
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Slightly worsened | 5 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Slightly improved | 22 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Much improved | 27 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Much improved | 24 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Unchanged | 41 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Unchanged | 34 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Slightly improved | 19 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Slightly worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Much improved | 24 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Unchanged | 68 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Slightly worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Slightly improved | 12 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Much improved | 16 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Very much improved | 3 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Slightly improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Unchanged | 38 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Slightly improved | 19 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Much improved | 27 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Unchanged | 38 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Unchanged | 23 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Slightly improved | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Much improved | 32 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | General Activities: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Unchanged | 30 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Much improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Walking ability: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Slightly worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Unchanged | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Slightly improved | 35 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Much improved | 21 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Daily living: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Unchanged | 49 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Slightly improved | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Much improved | 17 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Relationships: Very much improved | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Unchanged | 38 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Slightly improved | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Assessment of Patient Function (CAPF) at Week 8 | Enjoyment: Much improved | 25 Participants |
Secondary
Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period
The CGI-S is a clinician-rated scale that assesses the severity of the patient's pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories: * 1 normal-shows no sign of illness, * 2 borderline ill, * 3 mildly (slightly) ill, * 4 moderately ill, * 5 markedly ill, * 6 severely ill, and * 7 among the most extremely ill (Guy 1976). The clinician assesses the severity of the patient's condition, based on the clinician's total clinical experience with patients with this condition, in response to treatment. Endpoint values are the last observed postbaseline data.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 4 | 2.9 units on a scale | Standard Deviation 1.26 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Baseline | 3.0 units on a scale | Standard Deviation 1.19 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 8 | 2.8 units on a scale | Standard Deviation 1.21 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 12 | 2.8 units on a scale | Standard Deviation 1.19 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 2 | 2.9 units on a scale | Standard Deviation 1.2 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Endpoint | 2.9 units on a scale | Standard Deviation 1.18 |
| Placebo (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 1 | 2.9 units on a scale | Standard Deviation 1.16 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Endpoint | 2.8 units on a scale | Standard Deviation 1.12 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Baseline | 2.8 units on a scale | Standard Deviation 1.07 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 1 | 2.9 units on a scale | Standard Deviation 1.1 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 2 | 2.8 units on a scale | Standard Deviation 1.07 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 4 | 2.7 units on a scale | Standard Deviation 1.03 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 12 | 2.7 units on a scale | Standard Deviation 1.08 |
| Hydrocodone ER (Double-blind Treatment Period) | Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period | Week 8 | 2.7 units on a scale | Standard Deviation 1.01 |
Secondary
Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods
The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior. The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination.
Time frame: Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 1 | 2.9 units on a scale | Standard Deviation 3.7 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 8 | 2.5 units on a scale | Standard Deviation 3.51 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Double-blind Treatment | 3.7 units on a scale | Standard Deviation 4.12 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 12 | 2.8 units on a scale | Standard Deviation 3.51 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 4 | 2.4 units on a scale | Standard Deviation 3.1 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Endpoint | 3.0 units on a scale | Standard Deviation 3.67 |
| Placebo (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Open-Label Titration | 3.7 units on a scale | Standard Deviation 4.1 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Endpoint | 3.3 units on a scale | Standard Deviation 3.78 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Open-Label Titration | 4.2 units on a scale | Standard Deviation 4.14 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Baseline Double-blind Treatment | 3.9 units on a scale | Standard Deviation 4.29 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 1 | 3.1 units on a scale | Standard Deviation 3.1 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 4 | 2.8 units on a scale | Standard Deviation 3.31 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 8 | 2.2 units on a scale | Standard Deviation 2.87 |
| Hydrocodone ER (Double-blind Treatment Period) | Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods | Week 12 | 3.0 units on a scale | Standard Deviation 3.53 |
Secondary
Kaplan-Meier Estimates for Time to Discontinuation From the Study
Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.
Time frame: Day 1 to Week 12 of the double-blind treatment period
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo (Double-blind Treatment Period) | Kaplan-Meier Estimates for Time to Discontinuation From the Study | 99 days |
| Hydrocodone ER (Double-blind Treatment Period) | Kaplan-Meier Estimates for Time to Discontinuation From the Study | NA days |
Secondary
Participants With Adverse Events
An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time frame: Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period
Population: Safety analysis set (Open-Label Titration) and FAS (Double-Blind Treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Serious adverse event | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Severe adverse event | 9 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Withdrawals from treatment due to AE | 33 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Treatment-related adverse event | 90 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Deaths | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Any adverse event | 111 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Severe adverse event | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Any adverse event | 116 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Treatment-related adverse event | 72 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Serious adverse event | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Deaths | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Withdrawals from treatment due to AE | 15 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Any adverse event | 91 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Severe adverse event | 7 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Serious adverse event | 3 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Deaths | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Withdrawals from treatment due to AE | 3 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Adverse Events | Treatment-related adverse event | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Withdrawals from treatment due to AE | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Any adverse event | 93 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Severe adverse event | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Treatment-related adverse event | 48 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Deaths | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Adverse Events | Serious adverse event | 3 Participants |
Secondary
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 2 | 31 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 8 | 26 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 4 | 32 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 12 | 24 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 1 | 14 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 12 | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 1 | 13 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 2 | 15 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 4 | 17 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33% | Week 8 | 9 Participants |
Secondary
Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 2 | 16 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 8 | 20 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 4 | 19 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 12 | 15 Participants |
| Placebo (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 1 | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 12 | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 1 | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 2 | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 4 | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50% | Week 8 | 6 Participants |
Secondary
Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period
Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Uric acid: M\>=625, F\>=506 μmol/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 % * Urinalysis: blood (hemoglobin) and total protein: \>=2 unit increase from baseline
Time frame: Day 1 up to Day 128 in Double-Blind Treatment period
Population: Full analysis set including participants with laboratory assessments
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Hemoglobin | 1 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Hematocrit | 1 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Blood urea nitrogen | 1 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Uric acid | 2 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Urine blood | 2 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Urine total protein | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Urine blood | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Hemoglobin | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Uric acid | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Hematocrit | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Urine total protein | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period | Blood urea nitrogen | 4 Participants |
Secondary
Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period
Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg
Time frame: Day 1 up to Day 128 in Double-Blind Treatment period
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Systolic blood pressure - low | 1 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Diastolic blood pressure - low | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | At least one clinically significant vital sign | 2 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Pulse - high | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Pulse - low | 0 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Systolic blood pressure - high | 1 Participants |
| Placebo (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Diastolic blood pressure - high | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Systolic blood pressure - low | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Diastolic blood pressure - high | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Pulse - low | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Diastolic blood pressure - low | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | At least one clinically significant vital sign | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Systolic blood pressure - high | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period | Pulse - high | 0 Participants |
Secondary
Patient Assessment of Function (PAF) at Endpoint
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life Endpoint values are the last observed postbaseline data.
Time frame: Endpoint of the Double-blind Treatment Period (up to week 12)
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Slightly improved | 30 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Very much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Much improved | 19 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Very much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Slightly improved | 11 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Much worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Unchanged | 67 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Slightly worsened | 13 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Slightly improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Much worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Unchanged | 47 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Slightly worsened | 17 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Very much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Slightly improved | 28 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Much worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Much improved | 28 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Unchanged | 88 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Unchanged | 43 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Slightly improved | 12 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Unchanged | 47 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Very much worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Slightly improved | 31 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Very much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Much worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Unchanged | 59 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Slightly worsened | 13 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Slightly improved | 27 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Much improved | 27 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Unchanged | 52 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Very much improved | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Slightly worsened | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Unchanged | 39 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Much improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Go to Work: Very much improved | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Much worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Slightly worsened | 12 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Unchanged | 34 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Slightly improved | 39 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Much improved | 34 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Perform Work: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Slightly worsened | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Unchanged | 36 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Slightly improved | 40 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Much improved | 32 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Walk: Very much improved | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Very much worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Much worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Slightly worsened | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Unchanged | 51 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Slightly improved | 30 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Much improved | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Exercise: Very much improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Slightly worsened | 12 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Unchanged | 51 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Slightly improved | 30 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Much improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Social events: Very much improved | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Much worsened | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Slightly worsened | 12 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Unchanged | 76 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Slightly improved | 13 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Much worsened | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Much improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Sex: Very much improved | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Slightly worsened | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Unchanged | 45 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Slightly improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Endpoint | Enjoy life: Much improved | 35 Participants |
Secondary
Patient Assessment of Function (PAF) at Week 12
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Time frame: Week 12 of the Double-blind Treatment Period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Slightly improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Much improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Much improved | 15 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Much improved | 13 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Slightly improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Unchanged | 45 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Slightly improved | 16 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Slightly worsened | 5 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Much improved | 17 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Very much improved | 5 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Unchanged | 29 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Very much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Slightly improved | 20 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Unchanged | 64 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Much improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Slightly improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Unchanged | 27 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Very much improved | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Slightly worsened | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Very much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Unchanged | 26 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Unchanged | 36 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Slightly worsened | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Slightly improved | 21 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Slightly improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Much improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Unchanged | 34 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Very much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Slightly worsened | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Unchanged | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Slightly improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Much improved | 17 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Go to Work: Very much improved | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Much worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Slightly worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Unchanged | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Much improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Perform Work: Very much improved | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Slightly worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Unchanged | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Slightly improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Much improved | 23 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Walk: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Much worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Unchanged | 30 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Slightly improved | 26 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Much improved | 14 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Exercise: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Slightly worsened | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Unchanged | 29 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Slightly improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Much improved | 16 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Social events: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Slightly worsened | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Unchanged | 46 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Slightly improved | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Much improved | 12 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Sex: Very much improved | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Unchanged | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Slightly improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 12 | Enjoy life: Much improved | 24 Participants |
Secondary
Patient Assessment of Function (PAF) at Week 4
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Time frame: Week 4 of the Double-blind Treatment Period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Much improved | 22 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Unchanged | 34 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Slightly improved | 13 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Much improved | 12 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Slightly worsened | 11 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Unchanged | 33 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Slightly improved | 32 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Very much improved | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Unchanged | 37 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Slightly improved | 32 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Much improved | 27 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Much worsened | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Slightly worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Unchanged | 46 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Slightly improved | 30 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Much improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Slightly improved | 28 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Unchanged | 52 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Slightly improved | 26 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Much improved | 14 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Very much improved | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Much worsened | 5 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Unchanged | 66 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Slightly improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Much improved | 5 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Unchanged | 41 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Much improved | 20 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Very much improved | 11 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Unchanged | 31 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Slightly improved | 39 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Slightly worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Slightly improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Unchanged | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Much improved | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Slightly improved | 17 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Much improved | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Go to Work: Very much improved | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Much worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Unchanged | 64 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Slightly worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Unchanged | 20 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Very much improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Slightly improved | 38 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Slightly improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Much improved | 31 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Perform Work: Very much improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Unchanged | 37 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Much improved | 15 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Slightly worsened | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Slightly improved | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Unchanged | 24 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Much improved | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Slightly improved | 34 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Much improved | 22 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Much improved | 30 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Walk: Very much improved | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Social events: Very much improved | 13 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Unchanged | 34 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Sex: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Exercise: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 4 | Enjoy life: Very much worsened | 0 Participants |
Secondary
Patient Assessment of Function (PAF) at Week 8
The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study. The seven functional areas are: * ability to go to work * ability to perform at work (includes both work outside the home and housework) * ability to walk * ability to exercise * ability to participate in social events * ability to have sex * ability to enjoy life
Time frame: Week 8 of the Double-blind Treatment Period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Slightly improved | 24 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Slightly worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Unchanged | 74 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Slightly improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Very much improved | 4 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Slightly worsened | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Unchanged | 41 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Much improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Very much improved | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Unchanged | 31 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Slightly improved | 10 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Much improved | 14 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Very much improved | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Unchanged | 38 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Slightly improved | 22 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Much improved | 17 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Much worsened | 2 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Slightly worsened | 7 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Unchanged | 40 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Slightly improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Much improved | 17 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Very much improved | 9 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Very much worsened | 0 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Much worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Slightly worsened | 8 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Unchanged | 42 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Slightly improved | 23 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Much improved | 16 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Very much improved | 6 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Very much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Much worsened | 1 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Slightly worsened | 3 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Unchanged | 48 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Slightly improved | 18 Participants |
| Placebo (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Much improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Very much improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Slightly worsened | 6 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Slightly improved | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Unchanged | 22 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Slightly worsened | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Unchanged | 52 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Slightly improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Slightly improved | 12 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Much improved | 14 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Slightly worsened | 8 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Sex: Very much improved | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Very much improved | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Very much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Unchanged | 42 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Very much worsened | 1 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Unchanged | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Unchanged | 34 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Slightly improved | 25 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Much improved | 23 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Slightly worsened | 4 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Enjoy life: Very much improved | 7 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Slightly improved | 28 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Unchanged | 22 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Much worsened | 0 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Much improved | 33 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Much improved | 19 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Slightly worsened | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Slightly improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Unchanged | 29 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Much improved | 21 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Slightly improved | 9 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Much improved | 27 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Much improved | 18 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Social events: Slightly worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Go to Work: Very much improved | 3 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Walk: Very much improved | 10 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Very much worsened | 2 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Exercise: Very much improved | 5 Participants |
| Hydrocodone ER (Double-blind Treatment Period) | Patient Assessment of Function (PAF) at Week 8 | Perform Work: Much worsened | 0 Participants |
Secondary
Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason
Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.
Time frame: Day 1 to Week 12 of the double-blind treatment period
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Total withdrawn from study period | 31 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Protocol violation | 6 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Adverse event | 3 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Noncompliance to study procedures | 1 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Consent withdrawn | 2 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Noncompliance to study drug admin | 6 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Lack of efficacy | 12 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Other | 1 percentage of participants |
| Placebo (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Lost to follow-up | 0 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Other | 3 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Total withdrawn from study period | 36 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Lack of efficacy | 3 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Consent withdrawn | 3 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Lost to follow-up | 0 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Protocol violation | 10 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Noncompliance to study procedures | 1 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Noncompliance to study drug admin | 8 percentage of participants |
| Hydrocodone ER (Double-blind Treatment Period) | Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason | Adverse event | 7 percentage of participants |
Secondary
Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint
SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.
Time frame: Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Week 12 | 36.9 units on a scale | Standard Deviation 10.04 |
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Baseline | 52.8 units on a scale | Standard Deviation 9.99 |
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Baseline | 35.5 units on a scale | Standard Deviation 8.96 |
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Week 12 | 54.7 units on a scale | Standard Deviation 9.71 |
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Endpoint | 54.0 units on a scale | Standard Deviation 10.27 |
| Placebo (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Endpoint | 35.9 units on a scale | Standard Deviation 10.13 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Endpoint | 52.6 units on a scale | Standard Deviation 9.22 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Baseline | 35.8 units on a scale | Standard Deviation 9.28 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Week 12 | 37.6 units on a scale | Standard Deviation 9.04 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | PCS - Endpoint | 36.9 units on a scale | Standard Deviation 9.16 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Baseline | 52.8 units on a scale | Standard Deviation 10.47 |
| Hydrocodone ER (Double-blind Treatment Period) | Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint | MCS - Week 12 | 53.6 units on a scale | Standard Deviation 8.06 |
Secondary
Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period
The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.
Time frame: Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 2 | 5.4 units on a scale | Standard Deviation 5.59 |
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 8 | 3.4 units on a scale | Standard Deviation 4.68 |
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 1 | 5.9 units on a scale | Standard Deviation 5.39 |
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 4 | 5.5 units on a scale | Standard Deviation 6.16 |
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Endpoint | 3.6 units on a scale | Standard Deviation 4.96 |
| Placebo (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 12 | 3.2 units on a scale | Standard Deviation 4.73 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Endpoint | 4.3 units on a scale | Standard Deviation 6.3 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 1 | 6.1 units on a scale | Standard Deviation 5.93 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 2 | 4.4 units on a scale | Standard Deviation 5.1 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 4 | 5.3 units on a scale | Standard Deviation 5.37 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 8 | 3.2 units on a scale | Standard Deviation 4.23 |
| Hydrocodone ER (Double-blind Treatment Period) | Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period | Week 12 | 3.6 units on a scale | Standard Deviation 5.29 |
Secondary
Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period
The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Baseline | 3.75 units on a scale | Standard Deviation 0.903 |
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 1 | 3.73 units on a scale | Standard Deviation 1.319 |
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 2 | 3.89 units on a scale | Standard Deviation 1.498 |
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 4 | 3.78 units on a scale | Standard Deviation 1.702 |
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 8 | 3.68 units on a scale | Standard Deviation 1.823 |
| Placebo (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 12 | 3.61 units on a scale | Standard Deviation 1.783 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 8 | 3.16 units on a scale | Standard Deviation 1.461 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Baseline | 3.79 units on a scale | Standard Deviation 0.981 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 4 | 3.48 units on a scale | Standard Deviation 1.447 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 1 | 3.67 units on a scale | Standard Deviation 1.291 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 12 | 3.30 units on a scale | Standard Deviation 1.638 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period | Week 2 | 3.58 units on a scale | Standard Deviation 1.433 |
Secondary
Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period
The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period
Population: Full analysis set. Participants contributing to each time point are included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Baseline | 4.75 units on a scale | Standard Deviation 1.369 |
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 1 | 4.79 units on a scale | Standard Deviation 1.776 |
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 2 | 5.02 units on a scale | Standard Deviation 1.951 |
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 4 | 4.77 units on a scale | Standard Deviation 2.099 |
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 8 | 4.57 units on a scale | Standard Deviation 2.228 |
| Placebo (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 12 | 4.57 units on a scale | Standard Deviation 2.21 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 8 | 4.18 units on a scale | Standard Deviation 1.892 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Baseline | 4.85 units on a scale | Standard Deviation 1.265 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 4 | 4.55 units on a scale | Standard Deviation 1.832 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 1 | 4.79 units on a scale | Standard Deviation 1.636 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 12 | 4.22 units on a scale | Standard Deviation 1.873 |
| Hydrocodone ER (Double-blind Treatment Period) | Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period | Week 2 | 4.65 units on a scale | Standard Deviation 1.781 |