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
DRUGplacebo
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
* 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. * Acute liver injury (such as hepatitis) or severe cirrhosis. * Previous exposure to duloxetine. * Body Mass Index (BMI) over 40. * Major depressive disorder. * Daily use of narcotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Over 13 Weeks | This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster 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 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 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 Osteoarthritis Index (WOMAC) - Total Score | Baseline and 13 Weeks | The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). |
| Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score | Baseline and 13 Weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale. |
| Weekly Change From Baseline in the 24-Hour Worst Pain Score | Over 13 Weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale. |
| Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase | Baseline and 13 Weeks | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale. |
| Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity | Baseline and 13 Weeks | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - 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 - 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 - 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 - 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 Score - General Activity | Baseline and 13 Weeks | A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. 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 Score - 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). |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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 Score - 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). |
| Patient Global Impression of Improvement at 13 Week Endpoint | 13 Weeks | A scale that measures the patient's perception of improvement at the time of assessment. 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 Score - 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 Score - 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 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). |
| Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings | Over 13 Weeks | Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). |
| Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase | Over 13 Weeks | Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures. |
| Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary | Baseline and 13 Weeks | A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains. |
| Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline and 13 Weeks | A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains. |
| Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score | 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 - Total Score | 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 (HADS) - Anxiety Subscale | Baseline and 13 Weeks | A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' |
| Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase | Baseline and 13 Weeks | Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges. |
| Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid | Baseline and 13 Weeks | Change from baseline to endpoint in uric acid using central laboratory reference ranges. |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate | Baseline and 13 Weeks | Pulse rate (heart rate) measured in the sitting position. |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic | Baseline and 13 Weeks | Diastolic blood pressure measured in the sitting position. |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic | Baseline and 13 Weeks | Systolic blood pressure measured in the sitting position. |
| 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 Interference Score - 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). |
Countries
Puerto Rico, Romania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo daily (QD), by mouth (PO) for 13 weeks | 120 |
| Duloxetine 60mg /120mg Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group. | 111 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Initial Randomization | Adverse Event | 5 | 9 | 0 |
| Treatment Initial Randomization | Entry Criteria Not Met | 1 | 0 | 0 |
| Treatment Initial Randomization | Lack of Efficacy | 2 | 2 | 0 |
| Treatment Initial Randomization | Lost to Follow-up | 0 | 3 | 0 |
| Treatment Initial Randomization | Physician Decision | 1 | 0 | 0 |
| Treatment Initial Randomization | Protocol Violation | 0 | 1 | 0 |
| Treatment Initial Randomization | Sponsor Decision | 1 | 0 | 0 |
| Treatment Initial Randomization | Withdrawal by Subject | 7 | 7 | 0 |
| Treatment Re-Randomization | Adverse Event | 2 | 2 | 4 |
| Treatment Re-Randomization | Lack of Efficacy | 1 | 0 | 0 |
| Treatment Re-Randomization | Lost to Follow-up | 0 | 0 | 1 |
| Treatment Re-Randomization | Physician Decision | 1 | 3 | 0 |
| Treatment Re-Randomization | Protocol Violation | 1 | 1 | 0 |
| Treatment Re-Randomization | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Duloxetine 60mg /120mg | Total |
|---|---|---|---|
| Age Continuous | 62.48 years STANDARD_DEVIATION 9.3 | 62.07 years STANDARD_DEVIATION 9.63 | 62.28 years STANDARD_DEVIATION 9.44 |
| Brief Pain Inventory (BPI) Average Pain | 6.23 units on a scale STANDARD_DEVIATION 1.54 | 6.16 units on a scale STANDARD_DEVIATION 1.58 | 6.20 units on a scale STANDARD_DEVIATION 1.56 |
| Duration of Osteoarthritis (OA) Pain Since Onset | 9.30 years STANDARD_DEVIATION 8.27 | 9.04 years STANDARD_DEVIATION 8.72 | 9.17 years STANDARD_DEVIATION 8.47 |
| Duration of Osteoarthritis Since Diagnosis | 7.09 years STANDARD_DEVIATION 7.2 | 6.94 years STANDARD_DEVIATION 8.38 | 7.01 years STANDARD_DEVIATION 7.77 |
| Height | 164.67 centimeters STANDARD_DEVIATION 9.49 | 167.01 centimeters STANDARD_DEVIATION 8.81 | 165.79 centimeters STANDARD_DEVIATION 9.22 |
| Non Steroidal Anti Inflammatory Drug Use No | 61 participants | 53 participants | 114 participants |
| Non Steroidal Anti Inflammatory Drug Use Yes | 59 participants | 58 participants | 117 participants |
| Patient Global Impressions of Severity (PGI-Severity) | 2.40 units on a scale STANDARD_DEVIATION 1.64 | 2.21 units on a scale STANDARD_DEVIATION 1.51 | 2.31 units on a scale STANDARD_DEVIATION 1.58 |
| Race/Ethnicity, Customized African | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized Caucasian | 100 participants | 94 participants | 194 participants |
| Race/Ethnicity, Customized East Asian | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 10 participants | 9 participants | 19 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 81 Participants | 70 Participants | 151 Participants |
| Sex: Female, Male Male | 39 Participants | 41 Participants | 80 Participants |
| Weekly Mean of 24-Hour Average Pain Severity | 6.18 units on a scale STANDARD_DEVIATION 1.32 | 6.10 units on a scale STANDARD_DEVIATION 1.34 | 6.14 units on a scale STANDARD_DEVIATION 1.33 |
| Weight | 85.66 kilograms STANDARD_DEVIATION 15.12 | 85.57 kilograms STANDARD_DEVIATION 16.17 | 85.61 kilograms STANDARD_DEVIATION 15.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / — | 55 / — |
| serious Total, serious adverse events | 2 / — | 1 / — |
Outcome results
Primary
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).
Time frame: Over 13 Weeks
Population: Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 3 (Change from Baseline): N=110, N=97 | -1.23 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 7 (Change from Baseline): N=107, N=92 | -1.72 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 9 (Change from Baseline): N=98, N=81 | -1.89 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 8 (Change from Baseline): N=86, N=78 | -1.93 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 4 (Change from Baseline): N=109, N=96 | -1.42 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 10 (Change from Baseline): N=99, N=80 | -1.94 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 2 (Change from Baseline): N=112, N=101 | -0.95 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 11 (Change from Baseline): N=99, N=81 | -1.94 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 5 (Change from Baseline): N=107, N=90 | -1.55 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 12 (Change from Baseline): N=98, N=80 | -1.98 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 1 (Change from Baseline): N=119, N=103 | -0.36 units on a scale | Standard Error 0.15 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 13 (Change from Baseline): N=97, N=75 | -2.08 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 6 (Change from Baseline): N=108, N=92 | -1.61 units on a scale | Standard Error 0.15 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 13 (Change from Baseline): N=97, N=75 | -2.92 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 1 (Change from Baseline): N=119, N=103 | -0.84 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 2 (Change from Baseline): N=112, N=101 | -1.54 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 3 (Change from Baseline): N=110, N=97 | -1.85 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 4 (Change from Baseline): N=109, N=96 | -2.10 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 5 (Change from Baseline): N=107, N=90 | -2.29 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 6 (Change from Baseline): N=108, N=92 | -2.41 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 7 (Change from Baseline): N=107, N=92 | -2.60 units on a scale | Standard Error 0.16 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 9 (Change from Baseline): N=98, N=81 | -2.73 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 10 (Change from Baseline): N=99, N=80 | -2.74 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 11 (Change from Baseline): N=99, N=81 | -2.89 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 12 (Change from Baseline): N=98, N=80 | -2.93 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary | Week 8 (Change from Baseline): N=86, N=78 | -2.60 units on a scale | Standard Error 0.16 |
Comparison: Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).p-value: <0.001Mixed-Effects Model Repeated Measures
Secondary
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score
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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score | Baseline | 5.64 units on a scale | Standard Deviation 5.89 |
| Placebo | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score | Change from Baseline | -0.97 units on a scale | Standard Deviation 4.34 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score | Baseline | 5.49 units on a scale | Standard Deviation 6.84 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score | Change from Baseline | -1.26 units on a scale | Standard Deviation 3.88 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.64195% CI: [-1.19, 0.74]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference | Baseline | 4.72 units on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference | Change from Baseline | -1.79 units on a scale | Standard Deviation 2.1 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference | Baseline | 4.66 units on a scale | Standard Deviation 2.16 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference | Change from Baseline | -2.29 units on a scale | Standard Deviation 2.18 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.02995% CI: [-1.06, -0.06]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score | Baseline | 6.25 units on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score | Change from Baseline | -1.77 units on a scale | Standard Deviation 2.19 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score | Baseline | 6.19 units on a scale | Standard Deviation 1.59 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score | Change from Baseline | -2.71 units on a scale | Standard Deviation 2.43 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: <0.00195% CI: [-1.52, -0.42]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score | Baseline | 7.64 units on a scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score | Change from Baseline | -2.15 units on a scale | Standard Deviation 2.17 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score | Baseline | 7.60 units on a scale | Standard Deviation 1.38 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score | Change from Baseline | -3.17 units on a scale | Standard Deviation 2.72 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: <0.00195% CI: [-1.66, -0.46]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life | Baseline | 4.04 units on a scale | Standard Deviation 2.89 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life | Change from Baseline | -1.39 units on a scale | Standard Deviation 2.89 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life | Baseline | 4.42 units on a scale | Standard Deviation 3.06 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life | Change from Baseline | -2.38 units on a scale | Standard Deviation 3.03 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.01595% CI: [-1.4, -0.15]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity
A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity | Baseline | 5.55 units on a scale | Standard Deviation 2.23 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity | Change from Baseline | -1.97 units on a scale | Standard Deviation 2.72 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity | Baseline | 5.50 units on a scale | Standard Deviation 2.43 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity | Change from Baseline | -2.63 units on a scale | Standard Deviation 2.5 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.01995% CI: [-1.3, -0.12]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood | Baseline | 4.22 units on a scale | Standard Deviation 2.74 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood | Change from Baseline | -1.69 units on a scale | Standard Deviation 2.66 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood | Change from Baseline | -1.95 units on a scale | Standard Deviation 2.54 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood | Baseline | 4.06 units on a scale | Standard Deviation 2.66 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.16495% CI: [-0.97, 0.17]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work | Baseline | 5.80 units on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work | Change from Baseline | -2.25 units on a scale | Standard Deviation 2.48 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work | Baseline | 5.63 units on a scale | Standard Deviation 2.32 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work | Change from Baseline | -2.66 units on a scale | Standard Deviation 2.56 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.09395% CI: [-1.1, 0.08]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People | Baseline | 3.27 units on a scale | Standard Deviation 2.82 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People | Change from Baseline | -1.30 units on a scale | Standard Deviation 2.48 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People | Baseline | 3.05 units on a scale | Standard Deviation 2.81 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People | Change from Baseline | -1.43 units on a scale | Standard Deviation 2.51 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.28795% CI: [-0.82, 0.24]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep | Baseline | 4.16 units on a scale | Standard Deviation 2.98 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep | Change from Baseline | -1.57 units on a scale | Standard Deviation 2.87 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep | Baseline | 4.23 units on a scale | Standard Deviation 2.91 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep | Change from Baseline | -2.18 units on a scale | Standard Deviation 2.95 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.03395% CI: [-1.23, -0.05]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability | Baseline | 6.00 units on a scale | Standard Deviation 2.29 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability | Change from Baseline | -2.36 units on a scale | Standard Deviation 2.73 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability | Baseline | 5.72 units on a scale | Standard Deviation 2.26 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability | Change from Baseline | -2.80 units on a scale | Standard Deviation 2.87 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.04995% CI: [-1.25, 0]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score | Baseline | 5.09 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score | Change from Baseline | -1.60 units on a scale | Standard Deviation 2.13 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score | Baseline | 5.07 units on a scale | Standard Deviation 2.12 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score | Change from Baseline | -2.30 units on a scale | Standard Deviation 2.5 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00495% CI: [-1.28, -0.24]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score | Baseline | 6.02 units on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score | Change from Baseline | -2.26 units on a scale | Standard Deviation 2.83 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score | Baseline | 5.77 units on a scale | Standard Deviation 2.14 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score | Change from Baseline | -2.94 units on a scale | Standard Deviation 2.55 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00395% CI: [-1.5, -0.32]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity | Baseline | 2.62 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity | Change from Baseline | -0.21 units on a scale | Standard Deviation 1.28 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity | Baseline | 2.71 units on a scale | Standard Deviation 1.56 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity | Change from Baseline | -0.70 units on a scale | Standard Deviation 1.3 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00195% CI: [-0.56, -0.14]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score
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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score | Baseline | 0.70 units on a scale | Standard Deviation 0.16 |
| Placebo | Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score | Change from Baseline | 0.07 units on a scale | Standard Deviation 0.16 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score | Baseline | 0.68 units on a scale | Standard Deviation 0.18 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score | Change from Baseline | 0.14 units on a scale | Standard Deviation 0.19 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: <0.00195% CI: [0.03, 0.1]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Baseline | 5.36 units on a scale | Standard Deviation 3.86 |
| Placebo | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Change from Baseline | -0.93 units on a scale | Standard Deviation 2.58 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Baseline | 4.59 units on a scale | Standard Deviation 4.02 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | Change from Baseline | -1.15 units on a scale | Standard Deviation 3.12 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.19395% CI: [-1.17, 0.24]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary | Baseline | 56.58 units on a scale | Standard Deviation 10.38 |
| Placebo | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary | Change from Baseline | -1.03 units on a scale | Standard Deviation 9.34 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary | Baseline | 56.43 units on a scale | Standard Deviation 10.36 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary | Change from Baseline | 1.06 units on a scale | Standard Deviation 8.84 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.08895% CI: [-0.28, 3.94]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 30.57 units on a scale | Standard Deviation 8.13 |
| Placebo | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Change from Baseline | 6.36 units on a scale | Standard Deviation 9.24 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Baseline | 31.56 units on a scale | Standard Deviation 8.9 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary | Change from Baseline | 7.71 units on a scale | Standard Deviation 8.61 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.0895% CI: [-0.22, 3.96]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic
Diastolic blood pressure measured in the sitting position.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic | Baseline | 76.44 mm Hg | Standard Deviation 9.78 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic | Change from Baseline | -0.38 mm Hg | Standard Deviation 8.73 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic | Baseline | 77.00 mm Hg | Standard Deviation 8.82 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic | Change from Baseline | 0.95 mm Hg | Standard Deviation 8.46 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.32695% CI: [-1.1, 3.28]ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic
Systolic blood pressure measured in the sitting position.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic | Baseline | 129.42 mm Hg | Standard Deviation 14.44 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic | Change from Baseline | -2.29 mm Hg | Standard Deviation 12.35 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic | Baseline | 128.27 mm Hg | Standard Deviation 14.39 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic | Change from Baseline | 1.04 mm Hg | Standard Deviation 14.02 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.06995% CI: [-0.25, 6.56]ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate
Pulse rate (heart rate) measured in the sitting position.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate | Baseline | 70.07 beats per minute | Standard Deviation 8.32 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate | Change from Baseline | 1.26 beats per minute | Standard Deviation 7.52 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate | Baseline | 69.75 beats per minute | Standard Deviation 8.33 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate | Change from Baseline | 2.02 beats per minute | Standard Deviation 8.48 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.45995% CI: [-1.32, 2.92]ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline | 85.56 kilograms | Standard Deviation 15.14 |
| Placebo | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Change from Baseline | -0.33 kilograms | Standard Deviation 2.24 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline | 85.39 kilograms | Standard Deviation 16.25 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Change from Baseline | -0.79 kilograms | Standard Deviation 2.7 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.10795% CI: [-1.2, 0.12]ANOVA
Secondary
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase | Change from Baseline | -2.46 units on a scale | Standard Deviation 1.99 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase | Baseline | 5.96 units on a scale | Standard Deviation 1.41 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase | Change from Baseline | -3.44 units on a scale | Standard Deviation 1.76 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase | Baseline | 6.22 units on a scale | Standard Deviation 1.37 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.03995% CI: [-1.69, -0.05]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score | Baseline | 7.54 units on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score | Change from Baseline | -2.01 units on a scale | Standard Deviation 2.02 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score | Baseline | 7.45 units on a scale | Standard Deviation 1.12 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score | Change from Baseline | -2.81 units on a scale | Standard Deviation 2.4 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00595% CI: [-1.4, -0.25]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 10.95 units on a scale | Standard Deviation 3 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Change from Baseline | -3.19 units on a scale | Standard Deviation 3.87 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Baseline | 10.98 units on a scale | Standard Deviation 3.33 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale | Change from Baseline | -4.62 units on a scale | Standard Deviation 4.34 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00395% CI: [-2.33, -0.48]ANCOVA
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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 38.50 units on a scale | Standard Deviation 10.12 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Change from Baseline | -11.58 units on a scale | Standard Deviation 12.39 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Baseline | 39.10 units on a scale | Standard Deviation 11.06 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale | Change from Baseline | -16.46 units on a scale | Standard Deviation 14.65 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00195% CI: [-8.33, -2.03]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster 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: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.80 units on a scale | Standard Deviation 1.62 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Change from Baseline | -1.37 units on a scale | Standard Deviation 1.88 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Baseline | 4.74 units on a scale | Standard Deviation 1.59 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale | Change from Baseline | -1.97 units on a scale | Standard Deviation 2.16 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00495% CI: [-1.09, -0.22]ANCOVA
Secondary
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 53.36 units on a scale | Standard Deviation 14.73 |
| Placebo | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Change from Baseline | -15.93 units on a scale | Standard Deviation 17.53 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Baseline | 53.72 units on a scale | Standard Deviation 16.51 |
| Duloxetine 60mg /120mg | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score | Change from Baseline | -22.19 units on a scale | Standard Deviation 20.78 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.00495% CI: [-10.72, -2.11]ANCOVA
Secondary
Patient Global Impression of Improvement at 13 Week Endpoint
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Global Impression of Improvement at 13 Week Endpoint | 2.91 units on a scale | Standard Error 0.12 |
| Duloxetine 60mg /120mg | Patient Global Impression of Improvement at 13 Week Endpoint | 2.38 units on a scale | Standard Error 0.12 |
Comparison: An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.p-value: 0.00195% CI: [-0.84, -0.21]ANCOVA
Secondary
Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings
Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).
Time frame: Over 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings | 53 participants who responded |
| Duloxetine 60mg /120mg | Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings | 64 participants who responded |
Comparison: This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.p-value: 0.033Fisher Exact
Secondary
Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase
Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.
Time frame: Over 13 Weeks
Population: Number of re-randomized patients with non-missing response values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase | 26 participants who responded |
| Duloxetine 60mg /120mg | Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase | 32 participants who responded |
Comparison: This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.p-value: 0.075Fisher Exact
Secondary
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase
Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase | Baseline | 76.97 Units/Liter | Standard Deviation 21.75 |
| Placebo | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase | Change from Baseline | -1.94 Units/Liter | Standard Deviation 10.54 |
| Duloxetine 60mg /120mg | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase | Baseline | 78.59 Units/Liter | Standard Deviation 20.83 |
| Duloxetine 60mg /120mg | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase | Change from Baseline | 2.08 Units/Liter | Standard Deviation 12.95 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.003ANOVA
Secondary
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid
Change from baseline to endpoint in uric acid using central laboratory reference ranges.
Time frame: Baseline and 13 Weeks
Population: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid | Change from Baseline | 6.82 micromole/Liter | Standard Deviation 48.99 |
| Placebo | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid | Baseline | 314.57 micromole/Liter | Standard Deviation 77.12 |
| Duloxetine 60mg /120mg | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid | Change from Baseline | -5.00 micromole/Liter | Standard Deviation 47.9 |
| Duloxetine 60mg /120mg | Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid | Baseline | 322.77 micromole/Liter | Standard Deviation 95.86 |
Comparison: An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.p-value: 0.026ANOVA
Secondary
Weekly Change From Baseline in the 24-Hour Worst Pain Score
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Time frame: Over 13 Weeks
Population: Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 4 (Change from Baseline): N=109, N=96 | -1.41 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 8 (Change from Baseline): N=86, N=78 | -1.95 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 2 (Change from Baseline): N=112, N=101 | -0.92 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 9 (Change from Baseline): N=98, N=81 | -1.90 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 5 (Change from Baseline): N=107, N=90 | -1.49 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 10 (Change from Baseline): N=99, N=80 | -1.97 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 3 (Change from Baseline): N=110, N=97 | -1.20 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 11 (Change from Baseline): N=99, N=81 | -2.03 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 6 (Change from Baseline): N=108, N=92 | -1.57 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 12 (Change from Baseline): N=98, N=80 | -2.04 units on a scale | Standard Error 0.17 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 1 (Change from Baseline): N=119, N=103 | -0.31 units on a scale | Standard Error 0.16 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 13 (Change from Baseline): N=97, N=75 | -2.18 units on a scale | Standard Error 0.18 |
| Placebo | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 7 (Change from Baseline): N=107, N=92 | -1.71 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 13 (Change from Baseline): N=97, N=75 | -3.19 units on a scale | Standard Error 0.19 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 2 (Change from Baseline): N=112, N=101 | -1.57 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 3 (Change from Baseline): N=110, N=97 | -1.99 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 4 (Change from Baseline): N=109, N=96 | -2.26 units on a scale | Standard Error 0.17 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 5 (Change from Baseline): N=107, N=90 | -2.40 units on a scale | Standard Error 0.18 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 6 (Change from Baseline): N=108, N=92 | -2.58 units on a scale | Standard Error 0.18 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 7 (Change from Baseline): N=107, N=92 | -2.82 units on a scale | Standard Error 0.18 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 8 (Change from Baseline): N=86, N=78 | -2.82 units on a scale | Standard Error 0.18 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 9 (Change from Baseline): N=98, N=81 | -2.94 units on a scale | Standard Error 0.18 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 10 (Change from Baseline): N=99, N=80 | -3.00 units on a scale | Standard Error 0.19 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 11 (Change from Baseline): N=99, N=81 | -3.12 units on a scale | Standard Error 0.19 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 12 (Change from Baseline): N=98, N=80 | -3.14 units on a scale | Standard Error 0.19 |
| Duloxetine 60mg /120mg | Weekly Change From Baseline in the 24-Hour Worst Pain Score | Week 1 (Change from Baseline): N=119, N=103 | -0.82 units on a scale | Standard Error 0.17 |
p-value: <0.001Mixed-Effects Model Repeated Measures