Osteoarthritis Knee Pain
Conditions
Brief summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Interventions
DRUGDuloxetine
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
DRUGPlacebo
placebo every day (QD), by mouth (PO) for 13 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients with osteoarthritis knee pain.
Exclusion criteria
* Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * Previous exposure to duloxetine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Baseline, Week 4, Week 7, Week 13 | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale | Baseline and 13 Weeks | The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme). |
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale | Baseline and 13 Weeks | The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). |
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale | Baseline and 13 Weeks | The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme). |
| Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Baseline and 13 Weeks | This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline. |
| Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) | Baseline and 13 Weeks | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. |
| Number of Participants Who Responded to Treatment at 13 Week Endpoint | 13 Weeks | Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Baseline and 13 Weeks | MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30. |
| Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | Baseline and 13 Weeks | The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. |
| Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | Baseline and 13 Weeks | A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Baseline and 13 Weeks | A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score | Baseline and 13 Weeks | A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score | Baseline and 13 Weeks | A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score | Baseline and 13 Weeks | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score | Baseline and 13 Weeks | A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) | 13 Weeks | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference | Baseline and 13 Weeks | A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Adverse Events Reported as Reason for Discontinuation | over 13 weeks | — |
| Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Baseline and 13 Weeks | — |
| Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Baseline and 13 Week Endpoint | — |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Baseline and 13 Weeks | — |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Baseline and 13 Weeks | — |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline and 13 Weeks | — |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders | Baseline and 13 Weeks | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Non-Responders were defined as patients with a \<30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score. |
| Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint | 13 Weeks | Response was defined as a \>=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score. |
| Adverse Events Reported as Reason for Discontinuation in Nonresponders | over 13 Weeks | Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score. |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
Countries
Greece, Russia, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders | 128 |
| Placebo placebo every day (QD), by mouth (PO) for 13 weeks | 128 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 7 |
| Overall Study | Entry Criteria Not Met | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 5 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Duloxetine | Placebo | Total |
|---|---|---|---|
| Age Continuous | 63.16 years STANDARD_DEVIATION 8.75 | 61.90 years STANDARD_DEVIATION 9.2 | 62.53 years STANDARD_DEVIATION 8.98 |
| Body Mass Index | 29.44 kilograms/meters squared STANDARD_DEVIATION 4.66 | 29.65 kilograms/meters squared STANDARD_DEVIATION 4.52 | 29.55 kilograms/meters squared STANDARD_DEVIATION 4.58 |
| Body Weight | 81.05 kilograms STANDARD_DEVIATION 13.73 | 80.55 kilograms STANDARD_DEVIATION 12.24 | 80.80 kilograms STANDARD_DEVIATION 12.98 |
| Brief Pain Inventory Average Pain | 6.07 units on a scale STANDARD_DEVIATION 1.39 | 6.14 units on a scale STANDARD_DEVIATION 1.27 | 6.11 units on a scale STANDARD_DEVIATION 1.33 |
| Clinical Global Impressions of Severity Scale (CGI-S) | 3.34 units on a scale STANDARD_DEVIATION 1.21 | 3.34 units on a scale STANDARD_DEVIATION 1.33 | 3.34 units on a scale STANDARD_DEVIATION 1.27 |
| Duration of Osteoarthritis Pain Since Onset | 8.14 years STANDARD_DEVIATION 7.64 | 6.74 years STANDARD_DEVIATION 6.58 | 7.44 years STANDARD_DEVIATION 7.15 |
| Duration of Osteoarthritis Since Diagnosis | 6.16 years STANDARD_DEVIATION 5.88 | 5.62 years STANDARD_DEVIATION 6.2 | 5.89 years STANDARD_DEVIATION 6.04 |
| Height | 165.99 centimeters STANDARD_DEVIATION 8.69 | 165.02 centimeters STANDARD_DEVIATION 7.99 | 165.51 centimeters STANDARD_DEVIATION 8.34 |
| Nonsteroidal Anti-Inflammatory Drug (NSAID) Use No | 81 participants | 75 participants | 156 participants |
| Nonsteroidal Anti-Inflammatory Drug (NSAID) Use Yes | 47 participants | 53 participants | 100 participants |
| Race/Ethnicity African | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity Caucasian | 126 participants | 124 participants | 250 participants |
| Race/Ethnicity East Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity Hispanic | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Canada | 25 participants | 23 participants | 48 participants |
| Region of Enrollment Greece | 16 participants | 16 participants | 32 participants |
| Region of Enrollment Russian Federation | 62 participants | 65 participants | 127 participants |
| Region of Enrollment Sweden | 14 participants | 14 participants | 28 participants |
| Region of Enrollment United States | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 89 Participants | 107 Participants | 196 Participants |
| Sex: Female, Male Male | 39 Participants | 21 Participants | 60 Participants |
| Weekly Mean of 24 Hour Average Pain Severity | 6.02 units on a scale STANDARD_DEVIATION 1.18 | 6.07 units on a scale STANDARD_DEVIATION 1.26 | 6.04 units on a scale STANDARD_DEVIATION 1.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 64 / — | 41 / — |
| serious Total, serious adverse events | 3 / — | 2 / — |
Outcome results
Primary
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.
Time frame: Baseline, Week 4, Week 7, Week 13
Population: All randomized participants. Intent-to-treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 4 Change from Baseline (n=121, n=127) | -1.80 units on a scale | Standard Error 0.16 |
| Duloxetine | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 7 Change from Baseline (n=106, n=119) | -2.47 units on a scale | Standard Error 0.18 |
| Duloxetine | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 13 Change from Baseline (n=100, n=116) | -2.72 units on a scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 4 Change from Baseline (n=121, n=127) | -1.12 units on a scale | Standard Error 0.15 |
| Placebo | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 7 Change from Baseline (n=106, n=119) | -1.41 units on a scale | Standard Error 0.17 |
| Placebo | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | Week 13 Change from Baseline (n=100, n=116) | -1.88 units on a scale | Standard Error 0.18 |
Comparison: Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.p-value: <0.001Mixed Models Analysis
Comparison: Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.p-value: <0.001Mixed Models Analysis
Comparison: Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.p-value: <0.001Mixed Models Analysis
Secondary
Adverse Events Reported as Reason for Discontinuation
Time frame: over 13 weeks
Population: All randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Nausea | 5 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Abnormal dreams | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Asthenia | 2 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Haemorrhoids | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Anxiety | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Hot flush | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Insomnia | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Lethargy | 0 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Atrial fibrillation | 0 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Memory impairment | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Constipation | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Palpitations | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Pyelonephritis acute | 0 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Arthralgia | 2 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Sleep disorder | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Drug intolerance | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Supraventricular tachycardia | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Supraventricular tachycardia | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Insomnia | 2 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Arthralgia | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Asthenia | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Constipation | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Abnormal dreams | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Anxiety | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Atrial fibrillation | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Drug intolerance | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Haemorrhoids | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hot flush | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Lethargy | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Memory impairment | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Palpitations | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Pyelonephritis acute | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Sleep disorder | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Nausea | 0 participants |
Secondary
Adverse Events Reported as Reason for Discontinuation in Nonresponders
Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.
Time frame: over 13 Weeks
Population: Number of randomized participants who were nonresponders at Visit 4 (7 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Adverse Events Reported as Reason for Discontinuation in Nonresponders | Constipation | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation in Nonresponders | Nausea | 1 participants |
| Duloxetine | Adverse Events Reported as Reason for Discontinuation in Nonresponders | Arthralgia | 1 participants |
Secondary
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: Baseline and 13 Weeks
Population: All randomized participants. Intent-to-treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | Baseline | 4.29 units on a scale | Standard Deviation 6.27 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | Change from Baseline | -0.82 units on a scale | Standard Deviation 4.23 |
| Placebo | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | Baseline | 5.35 units on a scale | Standard Deviation 6.59 |
| Placebo | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | Change from Baseline | -1.25 units on a scale | Standard Deviation 3.9 |
p-value: 0.871ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Non-Responders were defined as patients with a \<30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score.
Time frame: Baseline and 13 Weeks
Population: Number of participants who did not respond to treatment after 6 weeks of treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders | Baseline | 5.30 units on a scale | Standard Deviation 1.61 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders | Change from Baseline | -0.76 units on a scale | Standard Deviation 2.03 |
p-value: 0.04t-test, 2 sided
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score | Baseline | 7.49 units on a scale | Standard Deviation 1.51 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score | Change from Baseline | -2.74 units on a scale | Standard Deviation 2.22 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score | Baseline | 7.50 units on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score | Change from Baseline | -1.94 units on a scale | Standard Deviation 2.29 |
p-value: 0.003ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference | Baseline | 3.91 units on a scale | Standard Deviation 1.98 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference | Change from Baseline | -1.93 units on a scale | Standard Deviation 2.05 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference | Baseline | 4.13 units on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference | Change from Baseline | -1.62 units on a scale | Standard Deviation 1.99 |
p-value: 0.082ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life | Baseline | 3.10 units on a scale | Standard Deviation 2.78 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life | Change from Baseline | -1.53 units on a scale | Standard Deviation 2.74 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life | Baseline | 3.29 units on a scale | Standard Deviation 2.73 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life | Change from Baseline | -1.23 units on a scale | Standard Deviation 2.73 |
p-value: 0.131ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | Baseline | 4.70 units on a scale | Standard Deviation 2.28 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | Change from Baseline | -2.26 units on a scale | Standard Deviation 2.49 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | Baseline | 5.17 units on a scale | Standard Deviation 2.18 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | Change from Baseline | -1.92 units on a scale | Standard Deviation 2.34 |
p-value: 0.05ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood | Baseline | 3.35 units on a scale | Standard Deviation 2.53 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood | Change from Baseline | -1.59 units on a scale | Standard Deviation 2.79 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood | Baseline | 3.60 units on a scale | Standard Deviation 2.64 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood | Change from Baseline | -1.72 units on a scale | Standard Deviation 2.58 |
p-value: 0.913ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work | Baseline | 4.77 units on a scale | Standard Deviation 2.39 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work | Change from Baseline | -2.43 units on a scale | Standard Deviation 2.49 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work | Baseline | 4.88 units on a scale | Standard Deviation 2.26 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work | Change from Baseline | -1.56 units on a scale | Standard Deviation 2.53 |
p-value: 0.001ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People | Baseline | 2.36 units on a scale | Standard Deviation 2.53 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People | Change from Baseline | -1.16 units on a scale | Standard Deviation 2.62 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People | Baseline | 2.37 units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People | Change from Baseline | -0.89 units on a scale | Standard Deviation 2.15 |
p-value: 0.26ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep | Baseline | 3.66 units on a scale | Standard Deviation 2.73 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep | Change from Baseline | -1.91 units on a scale | Standard Deviation 2.74 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep | Baseline | 4.02 units on a scale | Standard Deviation 2.73 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep | Change from Baseline | -1.91 units on a scale | Standard Deviation 2.77 |
p-value: 0.489ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability | Change from Baseline | -2.63 units on a scale | Standard Deviation 2.58 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability | Baseline | 5.41 units on a scale | Standard Deviation 2.26 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability | Change from Baseline | -2.07 units on a scale | Standard Deviation 2.61 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability | Baseline | 5.54 units on a scale | Standard Deviation 2.2 |
p-value: 0.066ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score | Baseline | 6.09 units on a scale | Standard Deviation 1.38 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score | Change from Baseline | -2.54 units on a scale | Standard Deviation 1.99 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score | Baseline | 6.16 units on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score | Change from Baseline | -1.78 units on a scale | Standard Deviation 2.1 |
p-value: <0.001ANCOVA
Comparison: Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.p-value: 0.002Regression, Linear
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score | Baseline | 4.70 units on a scale | Standard Deviation 1.8 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score | Change from Baseline | -1.95 units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score | Baseline | 4.63 units on a scale | Standard Deviation 1.86 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score | Change from Baseline | -1.24 units on a scale | Standard Deviation 2.4 |
p-value: 0.015ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline and 13 Weeks
Population: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score | Baseline | 5.45 units on a scale | Standard Deviation 1.96 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score | Change from Baseline | -2.57 units on a scale | Standard Deviation 2.29 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score | Baseline | 5.36 units on a scale | Standard Deviation 1.91 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score | Change from Baseline | -1.80 units on a scale | Standard Deviation 2.39 |
p-value: 0.007ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Time frame: Baseline and 13 Weeks
Population: All randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) | -0.63 units on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) | -0.32 units on a scale | Standard Deviation 1.32 |
p-value: 0.009ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | Baseline | 0.68 units on a scale | Standard Deviation 0.16 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | Change from Baseline | 0.09 units on a scale | Standard Deviation 0.16 |
| Placebo | Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | Baseline | 0.66 units on a scale | Standard Deviation 0.16 |
| Placebo | Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | Change from Baseline | 0.08 units on a scale | Standard Deviation 0.18 |
p-value: 0.209ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Baseline | 4.26 units on a scale | Standard Deviation 3.32 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Change from Baseline | -1.11 units on a scale | Standard Deviation 2.36 |
| Placebo | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Baseline | 4.16 units on a scale | Standard Deviation 3.52 |
| Placebo | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Change from Baseline | -0.69 units on a scale | Standard Deviation 2.44 |
p-value: 0.138ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
Time frame: Baseline and 13 Weeks
Population: Number of participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Systolic Blood Pressure (SBP) Baseline | 132.20 mm Hg | Standard Deviation 13.75 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | SBP Change from Baseline | -1.03 mm Hg | Standard Deviation 11.45 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Diastolic Blood Pressure (DBP) Baseline | 79.73 mm Hg | Standard Deviation 8.27 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | DBP Change from Baseline | 0.09 mm Hg | Standard Deviation 7.99 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | DBP Change from Baseline | 0.45 mm Hg | Standard Deviation 7.95 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Systolic Blood Pressure (SBP) Baseline | 131.42 mm Hg | Standard Deviation 16.13 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Diastolic Blood Pressure (DBP) Baseline | 79.83 mm Hg | Standard Deviation 9.26 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | SBP Change from Baseline | 0.89 mm Hg | Standard Deviation 12.93 |
p-value: 0.285ANOVA
p-value: 0.668ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
Time frame: Baseline and 13 Weeks
Population: Number of participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Baseline | 68.74 beats per minute | Standard Deviation 6.72 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Change from Baseline | 2.55 beats per minute | Standard Deviation 7.22 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Baseline | 69.73 beats per minute | Standard Deviation 7.76 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Change from Baseline | 0.06 beats per minute | Standard Deviation 6.47 |
p-value: 0.005ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Time frame: Baseline and 13 Weeks
Population: Number of participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Change from Baseline | -0.65 kilograms | Standard Deviation 2.01 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline | 81.01 kilograms | Standard Deviation 13.63 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Change from Baseline | 0.47 kilograms | Standard Deviation 1.94 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline | 80.49 kilograms | Standard Deviation 12.27 |
p-value: <0.001ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.
Time frame: Baseline and 13 Weeks
Population: All randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Baseline Weekly 24-Hour Average Pain | 6.05 units on a scale | Standard Deviation 1.16 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Change in Weekly 24-Hour Average Pain | -2.39 units on a scale | Standard Deviation 1.9 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Baseline Weekly 24-Hour Worst Pain | 7.58 units on a scale | Standard Deviation 1.26 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Change in Weekly 24-Hour Worst Pain | -2.57 units on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Change in Weekly 24-Hour Worst Pain | -2.05 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Baseline Weekly 24-Hour Average Pain | 6.08 units on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Baseline Weekly 24-Hour Worst Pain | 7.53 units on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | Change in Weekly 24-Hour Average Pain | -1.78 units on a scale | Standard Deviation 1.86 |
p-value: 0.008ANCOVA
p-value: 0.047ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).
Time frame: Baseline and 13 Weeks
Population: All randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale | Baseline | 35.05 units on a scale | Standard Deviation 9.63 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale | Change from Baseline | -13.78 units on a scale | Standard Deviation 10.78 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale | Baseline | 36.82 units on a scale | Standard Deviation 8.15 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale | Change from Baseline | -10.75 units on a scale | Standard Deviation 10.98 |
p-value: 0.016ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).
Time frame: Baseline and 13 Weeks
Population: All randomized participants with baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale | Baseline | 10.24 units on a scale | Standard Deviation 2.47 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale | Change from Baseline | -4.27 units on a scale | Standard Deviation 3.3 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale | Baseline | 10.35 units on a scale | Standard Deviation 2.66 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale | Change from Baseline | -3.49 units on a scale | Standard Deviation 3.89 |
p-value: 0.068ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).
Time frame: Baseline and 13 Weeks
Population: All randomized participants with baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale | Baseline | 4.27 units on a scale | Standard Deviation 1.36 |
| Duloxetine | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale | Change from Baseline | -1.63 units on a scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale | Baseline | 4.50 units on a scale | Standard Deviation 1.34 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale | Change from Baseline | -1.36 units on a scale | Standard Deviation 1.71 |
p-value: 0.064ANCOVA
Secondary
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.
Time frame: Baseline and 13 Weeks
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Health Change from Baseline | 0.64 units on a scale | Standard Deviation 3.31 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Component Summary Change from Baseline | 7.26 units on a scale | Standard Deviation 8.55 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Functioning Baseline (n=120, n=125) | 17.48 units on a scale | Standard Deviation 3.9 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Functioning Change from Baseline | 2.95 units on a scale | Standard Deviation 4.17 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Bodily Pain Baseline (n=121, n=124) | 5.77 units on a scale | Standard Deviation 1.25 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Emotional Baseline (n=121, n=125) | 5.05 units on a scale | Standard Deviation 1.19 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Component Summary Change from Baseline | 0.35 units on a scale | Standard Deviation 8.11 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Emotional Change from Baseline | 0.35 units on a scale | Standard Deviation 1.22 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Bodily Pain Change from Baseline | 1.64 units on a scale | Standard Deviation 1.7 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Physical Baseline (n=121, n=125) | 5.31 units on a scale | Standard Deviation 1.44 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | General Health Baseline (n=120, n=122) | 17.02 units on a scale | Standard Deviation 4.38 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Physical Change from Baseline | 1.03 units on a scale | Standard Deviation 1.8 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Component Summary Baseline (n=119, n=121) | 55.86 units on a scale | Standard Deviation 10 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Social Functioning Baseline (n=121, n=125) | 8.18 units on a scale | Standard Deviation 1.76 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | General Health Change from Baseline | 1.15 units on a scale | Standard Deviation 2.96 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Social Functioning Change from Baseline | 0.44 units on a scale | Standard Deviation 1.63 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Component Summary Baseline (n=119, n=121) | 30.59 units on a scale | Standard Deviation 7.37 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Health Baseline (n=121, n=124) | 24.13 units on a scale | Standard Deviation 4.06 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Vitality Change from Baseline | 1.04 units on a scale | Standard Deviation 3.46 |
| Duloxetine | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Vitality Baseline (n=121, n=124) | 16.10 units on a scale | Standard Deviation 3.84 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Vitality Change from Baseline | 0.81 units on a scale | Standard Deviation 3.03 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Bodily Pain Change from Baseline | 1.12 units on a scale | Standard Deviation 1.76 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Functioning Baseline (n=120, n=125) | 16.38 units on a scale | Standard Deviation 3.58 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Component Summary Baseline (n=119, n=121) | 54.47 units on a scale | Standard Deviation 10.16 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Component Summary Change from Baseline | 1.10 units on a scale | Standard Deviation 8.3 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Component Summary Baseline (n=119, n=121) | 28.70 units on a scale | Standard Deviation 6.87 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Bodily Pain Baseline (n=121, n=124) | 5.58 units on a scale | Standard Deviation 1.22 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | General Health Baseline (n=120, n=122) | 16.61 units on a scale | Standard Deviation 4.28 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | General Health Change from Baseline | 0.64 units on a scale | Standard Deviation 3.18 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Health Baseline (n=121, n=124) | 23.67 units on a scale | Standard Deviation 4.17 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Mental Health Change from Baseline | 0.56 units on a scale | Standard Deviation 3.46 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Functioning Change from Baseline | 2.16 units on a scale | Standard Deviation 3.76 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Emotional Baseline (n=121, n=125) | 4.76 units on a scale | Standard Deviation 1.26 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Emotional Change from Baseline | 0.40 units on a scale | Standard Deviation 1.22 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Physical Baseline (n=121, n=125) | 4.96 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Role-Physical Change from Baseline | 0.70 units on a scale | Standard Deviation 1.66 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Social Functioning Baseline (n=121, n=125) | 7.78 units on a scale | Standard Deviation 1.69 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Social Functioning Change from Baseline | 0.44 units on a scale | Standard Deviation 1.74 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Vitality Baseline (n=121, n=124) | 15.43 units on a scale | Standard Deviation 3.69 |
| Placebo | Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores | Physical Component Summary Change from Baseline | 4.76 units on a scale | Standard Deviation 7.93 |
p-value: 0.897ANCOVA
p-value: <0.001ANCOVA
p-value: 0.004ANCOVA
p-value: 0.051ANCOVA
p-value: 0.508ANCOVA
p-value: 0.019ANCOVA
p-value: 0.415ANCOVA
p-value: 0.006ANCOVA
p-value: 0.342ANCOVA
p-value: 0.135ANCOVA
Secondary
Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: 13 Weeks
Population: All randomized participants with at least one non-missing post-baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) | 2.85 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) | 3.09 units on a scale | Standard Deviation 1.08 |
p-value: 0.164ANCOVA
Secondary
Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint
Response was defined as a \>=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.
Time frame: 13 Weeks
Population: Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint | 9 participants |
Secondary
Number of Participants Who Responded to Treatment at 13 Week Endpoint
Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: 13 Weeks
Population: Number of randomized participants with non-missing response values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Participants Who Responded to Treatment at 13 Week Endpoint | 79 participants |
| Placebo | Number of Participants Who Responded to Treatment at 13 Week Endpoint | 56 participants |
p-value: <0.001Fisher Exact
Secondary
Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
Time frame: Baseline and 13 Week Endpoint
Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Baseline | 104.38 millimole per Liter | Standard Deviation 2.26 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Change from Baseline | -0.83 millimole per Liter | Standard Deviation 2.62 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Baseline | 104.18 millimole per Liter | Standard Deviation 2.43 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Change from Baseline | -0.08 millimole per Liter | Standard Deviation 2.66 |
p-value: 0.042ANOVA
Secondary
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Time frame: Baseline and 13 Weeks
Population: Number of participants with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Alkaline Phosphatase Baseline (n=120,n=126) | 77.33 Units/Liter | Standard Deviation 22.91 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Alkaline Phosphatase Change from Baseline | 2.38 Units/Liter | Standard Deviation 15.74 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Aspartate Amino Transaminase (AST) Baseline | 22.61 Units/Liter | Standard Deviation 7.89 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | AST Change from Baseline (n=117,n=124) | 1.44 Units/Liter | Standard Deviation 8.32 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Gammaglutamyl Transpeptidase (GGT) Baseline | 25.56 Units/Liter | Standard Deviation 17.56 |
| Duloxetine | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | GGT Change from Baseline (n=120,n=126) | 5.33 Units/Liter | Standard Deviation 20.4 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Gammaglutamyl Transpeptidase (GGT) Baseline | 30.55 Units/Liter | Standard Deviation 30.72 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Alkaline Phosphatase Baseline (n=120,n=126) | 75.90 Units/Liter | Standard Deviation 22.3 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | AST Change from Baseline (n=117,n=124) | -1.37 Units/Liter | Standard Deviation 7.26 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Alkaline Phosphatase Change from Baseline | -3.43 Units/Liter | Standard Deviation 14.56 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | GGT Change from Baseline (n=120,n=126) | -2.10 Units/Liter | Standard Deviation 19.12 |
| Placebo | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Aspartate Amino Transaminase (AST) Baseline | 24.23 Units/Liter | Standard Deviation 11.1 |
p-value: <0.001ANOVA
p-value: 0.01ANOVA
p-value: 0.023ANOVA