Chronic Low Back Pain
Conditions
Brief summary
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.
Interventions
DRUGDuloxetine
60 mg orally once daily for 12 weeks
DRUGPlacebo
Placebo once daily orally for 12 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients with chronic low back 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 |
|---|---|---|
| Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score | baseline, 12 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). Least Squares Mean values were controlled for investigator and baseline severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | baseline, 12 weeks | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. |
| Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | baseline, 12 weeks | 24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity. |
| Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 12 weeks | Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is 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). Response was assessed at endpoint. |
| Number of Sustained Responders at 12 Week Endpoint | 12 weeks | Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: 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). Number of sustained responders was assessed at endpoint. |
| Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | 12 weeks | The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: 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). Number of participants under each threshold was assessed at endpoint. |
| Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) | baseline, 12 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). Least Squares Mean values were controlled for investigator and baseline severity. |
| Patient's Global Impression of Improvement (PGI-I) at 12 Weeks | 12 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). Least Squares Mean values were controlled for investigator and baseline severity. |
| Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire | baseline, 12 weeks | Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity. |
| Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | baseline, 12 weeks | The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed). |
| Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | baseline, 12 weeks | The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning). |
| Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | baseline, 12 weeks | Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score. |
| Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | baseline, 12 weeks | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. 1. Absenteeism 2. Presenteeism 3. Work productivity loss 4. Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. |
| Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 12 weeks | Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is 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). Response was assessed at endpoint. |
| Change From Baseline to 12 Weeks in Uric Acid | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Albumin | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Creatinine | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Total Protein | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Weeks in Blood Pressure | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Weight | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Change From Baseline to 12 Week Endpoint in Pulse Rate | baseline, 12 weeks | Least Squares Mean values were controlled for investigator. |
| Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale | baseline through 12 weeks | The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. |
| Participants Who Discontinued From Baseline to 12 Weeks | baseline, 12 weeks | Reasons for discontinuation are listed in the participant flow. |
Countries
Brazil, Germany, Netherlands, Poland, Russia, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment | 198 |
| Placebo Patients received placebo by mouth once daily for 12 weeks of double-blind treatment | 203 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 30 | 11 |
| Overall Study | Entry Criteria Not Met | 1 | 1 |
| Overall Study | Lack of Efficacy | 1 | 9 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Physician Decision | 4 | 3 |
| Overall Study | Protocol Violation | 6 | 5 |
| Overall Study | Sponsor Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 13 |
Baseline characteristics
| Characteristic | Total | Placebo | Duloxetine |
|---|---|---|---|
| Age Continuous | 54.14 years STANDARD_DEVIATION 13.73 | 53.43 years STANDARD_DEVIATION 14.17 | 54.87 years STANDARD_DEVIATION 13.27 |
| Body Mass Index (BMI) | 27.85 kilogram/meter squared STANDARD_DEVIATION 4.62 | 28.14 kilogram/meter squared STANDARD_DEVIATION 4.72 | 27.56 kilogram/meter squared STANDARD_DEVIATION 4.5 |
| Brief Pain Inventory Average Pain Rating | 5.79 units on a scale STANDARD_DEVIATION 1.4 | 5.75 units on a scale STANDARD_DEVIATION 1.37 | 5.84 units on a scale STANDARD_DEVIATION 1.43 |
| Clinical Global Impression - Severity (CGI-S) | 3.39 units on a scale STANDARD_DEVIATION 1.27 | 3.29 units on a scale STANDARD_DEVIATION 1.28 | 3.49 units on a scale STANDARD_DEVIATION 1.24 |
| Duration of Chronic Lower Back Pain | 8.51 years STANDARD_DEVIATION 8.57 | 8.74 years STANDARD_DEVIATION 8.95 | 8.28 years STANDARD_DEVIATION 8.18 |
| Height | 168.07 centimeter STANDARD_DEVIATION 9.22 | 167.91 centimeter STANDARD_DEVIATION 8.82 | 168.24 centimeter STANDARD_DEVIATION 9.64 |
| Quebec Task Force on Spinal Disorders Class 1 | 341 participants | 168 participants | 173 participants |
| Quebec Task Force on Spinal Disorders Class 2 | 51 participants | 30 participants | 21 participants |
| Quebec Task Force on Spinal Disorders Not Available | 9 participants | 5 participants | 4 participants |
| Race/Ethnicity, Customized African | 10 participants | 5 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 382 participants | 193 participants | 189 participants |
| Race/Ethnicity, Customized Hispanic | 8 participants | 4 participants | 4 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Germany | 49 participants | 26 participants | 23 participants |
| Region of Enrollment Netherlands | 32 participants | 16 participants | 16 participants |
| Region of Enrollment Poland | 70 participants | 35 participants | 35 participants |
| Region of Enrollment Russian Federation | 68 participants | 33 participants | 35 participants |
| Region of Enrollment Spain | 51 participants | 26 participants | 25 participants |
| Region of Enrollment United States | 131 participants | 67 participants | 64 participants |
| Roland Morris Disability Questionnaire | 9.47 units on a scale STANDARD_DEVIATION 4.7 | 9.32 units on a scale STANDARD_DEVIATION 4.77 | 9.63 units on a scale STANDARD_DEVIATION 4.64 |
| Sex: Female, Male Female | 246 Participants | 128 Participants | 118 Participants |
| Sex: Female, Male Male | 155 Participants | 75 Participants | 80 Participants |
| Weekly mean of 24-hour average pain rating using an 11-point numerical scale patient diary | 5.80 units on a scale STANDARD_DEVIATION 1.36 | 5.80 units on a scale STANDARD_DEVIATION 1.37 | 5.79 units on a scale STANDARD_DEVIATION 1.36 |
| Weight | 78.83 kilogram STANDARD_DEVIATION 15.23 | 79.35 kilogram STANDARD_DEVIATION 14.65 | 78.30 kilogram STANDARD_DEVIATION 15.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 123 / 198 | 112 / 203 |
| serious Total, serious adverse events | 5 / 198 | 0 / 203 |
Outcome results
Primary
Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
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). Least Squares Mean values were controlled for investigator and baseline severity.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score | -2.48 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score | -1.80 units on a scale | Standard Error 0.15 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.p-value: 0.001Mixed Models Analysis
Secondary
Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.~endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase | 1.51 Units/Liter | Standard Error 1.01 |
| Placebo | Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase | -1.71 Units/Liter | Standard Error 1.01 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.p-value: 0.013ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Albumin
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Albumin | -0.76 Gram/Liter | Standard Deviation 0.23 |
| Placebo | Change From Baseline to 12 Week Endpoint in Albumin | -0.12 Gram/Liter | Standard Deviation 0.23 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.p-value: 0.031ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase | 1.59 Units/Liter | Standard Error 0.94 |
| Placebo | Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase | -1.85 Units/Liter | Standard Error 0.94 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.p-value: 0.004ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase | 1.90 Units/Liter | Standard Error 0.92 |
| Placebo | Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase | -0.54 Units/Liter | Standard Error 0.92 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.p-value: 0.039ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Creatinine
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Creatinine | -1.69 Micromole/Liter | Standard Error 0.82 |
| Placebo | Change From Baseline to 12 Week Endpoint in Creatinine | 0.70 Micromole/Liter | Standard Error 0.82 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.p-value: 0.024ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Pulse Rate
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Pulse Rate | 0.18 beats per minute | Standard Error 0.65 |
| Placebo | Change From Baseline to 12 Week Endpoint in Pulse Rate | -0.17 beats per minute | Standard Error 0.64 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.p-value: 0.68ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Total Protein
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Total Protein | -1.34 Gram/Liter | Standard Error 0.3 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total Protein | -0.43 Gram/Liter | Standard Error 0.3 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.p-value: 0.019ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Weight
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Week Endpoint in Weight | -0.31 kilogram | Standard Error 0.17 |
| Placebo | Change From Baseline to 12 Week Endpoint in Weight | 0.05 kilogram | Standard Error 0.17 |
Secondary
Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)
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). Least Squares Mean values were controlled for investigator and baseline severity.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) | -0.95 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) | -0.79 units on a scale | Standard Error 0.07 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.p-value: 0.07795% CI: [-0.33, 0.02]ANCOVA
Secondary
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Component - baseline; n=147, n=153 | 34.41 units on a scale | Standard Deviation 8.18 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Component - change; n=147, n=153 | 6.15 units on a scale | Standard Deviation 8.85 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Component - baseline; n=147, n=153 | 49.50 units on a scale | Standard Deviation 12.33 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Component - change; n=147, n=153 | 3.34 units on a scale | Standard Deviation 9.26 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Bodily Pain - baseline; n=188, n=190 | 33.37 units on a scale | Standard Deviation 13.94 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Bodily Pain -change; n=188, n=190 | 18.31 units on a scale | Standard Deviation 19.25 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Health - baseline; n=165, n=166 | 69.30 units on a scale | Standard Deviation 19.19 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Health - change; n=165, n=166 | 6.65 units on a scale | Standard Deviation 15.98 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | General Health - baseline; n=188, n=190 | 53.54 units on a scale | Standard Deviation 19.31 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | General Health - change; n=188, n=190 | 7.81 units on a scale | Standard Deviation 17.94 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Emotional - change; n=172, n=179 | 8.19 units on a scale | Standard Deviation 21.9 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Functioning - baseline;n=186, n=189 | 50.02 units on a scale | Standard Deviation 22.63 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Functioning - change; n=186, n=189 | 13.18 units on a scale | Standard Deviation 20.48 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Emotional - baseline; n=172, n=179 | 73.89 units on a scale | Standard Deviation 26.63 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Physical - baseline; n=172, n=179 | 46.77 units on a scale | Standard Deviation 22.37 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Physical - change; n=172, n=179 | 12.97 units on a scale | Standard Deviation 22.24 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Social Functioning -baseline; n=188, n=190 | 67.02 units on a scale | Standard Deviation 24.28 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Social Functioning - change; n=188, n=190 | 12.70 units on a scale | Standard Deviation 22.18 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Vitality - baseline; n=163, n=165 | 50.69 units on a scale | Standard Deviation 19.08 |
| Duloxetine | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Vitality - change; n=163, n=165 | 9.33 units on a scale | Standard Deviation 18.94 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Social Functioning - change; n=188, n=190 | 7.11 units on a scale | Standard Deviation 21.02 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Component - baseline; n=147, n=153 | 34.29 units on a scale | Standard Deviation 7.75 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Physical - change; n=172, n=179 | 11.66 units on a scale | Standard Deviation 22.89 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Component - change; n=147, n=153 | 5.22 units on a scale | Standard Deviation 8.25 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Functioning - baseline;n=186, n=189 | 52.13 units on a scale | Standard Deviation 21.17 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Component - baseline; n=147, n=153 | 49.59 units on a scale | Standard Deviation 10.35 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Vitality - change; n=163, n=165 | 6.30 units on a scale | Standard Deviation 18.4 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Component - change; n=147, n=153 | 0.84 units on a scale | Standard Deviation 8.58 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Physical Functioning - change; n=186, n=189 | 9.42 units on a scale | Standard Deviation 17.63 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Bodily Pain - baseline; n=188, n=190 | 33.93 units on a scale | Standard Deviation 13.81 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Social Functioning -baseline; n=188, n=190 | 69.67 units on a scale | Standard Deviation 24.03 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Bodily Pain -change; n=188, n=190 | 13.52 units on a scale | Standard Deviation 20.15 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Emotional - baseline; n=172, n=179 | 74.21 units on a scale | Standard Deviation 25.64 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Health - baseline; n=165, n=166 | 69.72 units on a scale | Standard Deviation 16.73 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Emotional - change; n=172, n=179 | 5.12 units on a scale | Standard Deviation 23.52 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Mental Health - change; n=165, n=166 | 1.48 units on a scale | Standard Deviation 14.21 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Vitality - baseline; n=163, n=165 | 48.64 units on a scale | Standard Deviation 18.92 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | General Health - baseline; n=188, n=190 | 53.11 units on a scale | Standard Deviation 22.12 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | Role-Physical - baseline; n=172, n=179 | 46.42 units on a scale | Standard Deviation 23.68 |
| Placebo | Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | General Health - change; n=188, n=190 | 5.34 units on a scale | Standard Deviation 18.06 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.p-value: 0.16895% CI: [-0.53, 3.02]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.p-value: 0.0195% CI: [0.53, 3.96]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.p-value: 0.01695% CI: [0.86, 8.3]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.p-value: <0.00195% CI: [2.15, 7.61]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.p-value: 0.10195% CI: [-0.5, 5.67]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.p-value: 0.05895% CI: [-0.12, 7.12]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.p-value: 0.22795% CI: [-1.52, 6.37]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.p-value: 0.38395% CI: [-2.39, 6.21]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.p-value: 0.0395% CI: [0.38, 7.61]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.p-value: 0.02295% CI: [0.59, 7.6]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Blood Pressure
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Blood Pressure | Systolic Blood Pressure (millimeter mercury) | 0.49 millimeter mercury | Standard Error 0.85 |
| Duloxetine | Change From Baseline to 12 Weeks in Blood Pressure | Diastolic Blood Pressure (millimeter mercury) | -0.14 millimeter mercury | Standard Error 0.67 |
| Placebo | Change From Baseline to 12 Weeks in Blood Pressure | Systolic Blood Pressure (millimeter mercury) | -0.59 millimeter mercury | Standard Error 0.85 |
| Placebo | Change From Baseline to 12 Weeks in Blood Pressure | Diastolic Blood Pressure (millimeter mercury) | -0.64 millimeter mercury | Standard Error 0.67 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.p-value: 0.329ANOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.p-value: 0.562ANOVA
Secondary
Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | UK population-based Index Score-baseline | 0.52 units on a scale | Standard Deviation 0.27 |
| Duloxetine | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | UK population-based Index Score-change | 0.19 units on a scale | Standard Deviation 0.31 |
| Duloxetine | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | US population-based Index Score-baseline | 0.66 units on a scale | Standard Deviation 0.17 |
| Duloxetine | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | US population-based Index Score-change | 0.12 units on a scale | Standard Deviation 0.21 |
| Placebo | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | US population-based Index Score-change | 0.05 units on a scale | Standard Deviation 0.17 |
| Placebo | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | UK population-based Index Score-baseline | 0.57 units on a scale | Standard Deviation 0.24 |
| Placebo | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | US population-based Index Score-baseline | 0.69 units on a scale | Standard Deviation 0.16 |
| Placebo | Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | UK population-based Index Score-change | 0.07 units on a scale | Standard Deviation 0.26 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.p-value: <0.00195% CI: [0.03, 0.12]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.p-value: 0.00295% CI: [0.02, 0.08]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Tension-Anxiety - baseline; n=186,n=185 | 4.22 units on a scale | Standard Deviation 3.78 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Tension-Anxiety - change; n=186,n=185 | -1.58 units on a scale | Standard Deviation 3.48 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Depression-Dejection - baseline; n=185,n=188 | 2.67 units on a scale | Standard Deviation 3.63 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Depression-Dejection - change; n=185,n=188 | -0.80 units on a scale | Standard Deviation 3.28 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Anger-Hostility - baseline; n=186,n=185 | 2.79 units on a scale | Standard Deviation 3.6 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Anger-Hostility - change; n=186,n=185 | -1.18 units on a scale | Standard Deviation 3.07 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Vigor-Activity - baseline; n=185, n=187 | 6.77 units on a scale | Standard Deviation 4.3 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Vigor-Activity - change; n=185, n=187 | 2.13 units on a scale | Standard Deviation 4.53 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Confusion-Bewilderment - change; n=185, n=187 | -0.69 units on a scale | Standard Deviation 2.71 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Fatigue-Inertia - baseline; n=184, n=188 | 6.49 units on a scale | Standard Deviation 4.33 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Fatigue-Inertia - change; n=184, n=188 | -1.74 units on a scale | Standard Deviation 3.96 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Confusion-Bewilderment - baseline; n=185, n=187 | 4.09 units on a scale | Standard Deviation 2.89 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Total Mood Disturbance - baseline; n=181, n=180 | 13.31 units on a scale | Standard Deviation 16.67 |
| Duloxetine | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Total Mood Disturbance - change; n=181, n=180 | -7.90 units on a scale | Standard Deviation 14.06 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Total Mood Disturbance - baseline; n=181, n=180 | 14.27 units on a scale | Standard Deviation 17.39 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Tension-Anxiety - baseline; n=186,n=185 | 4.29 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Vigor-Activity - change; n=185, n=187 | 0.81 units on a scale | Standard Deviation 3.88 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Tension-Anxiety - change; n=186,n=185 | -0.78 units on a scale | Standard Deviation 3.17 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Confusion-Bewilderment - baseline; n=185, n=187 | 4.07 units on a scale | Standard Deviation 2.79 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Depression-Dejection - baseline; n=185,n=188 | 2.74 units on a scale | Standard Deviation 3.44 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Confusion-Bewilderment - change; n=185, n=187 | -0.14 units on a scale | Standard Deviation 2.47 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Depression-Dejection - change; n=185,n=188 | -0.45 units on a scale | Standard Deviation 3.07 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Fatigue-Inertia - baseline; n=184, n=188 | 6.71 units on a scale | Standard Deviation 4.67 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Anger-Hostility - baseline; n=186,n=185 | 3.46 units on a scale | Standard Deviation 4.11 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Total Mood Disturbance - change; n=181, n=180 | -4.68 units on a scale | Standard Deviation 14.54 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Anger-Hostility - change; n=186,n=185 | -0.63 units on a scale | Standard Deviation 3.38 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Fatigue-Inertia - change; n=184, n=188 | -1.64 units on a scale | Standard Deviation 4.31 |
| Placebo | Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | Vigor-Activity - baseline; n=185, n=187 | 7.23 units on a scale | Standard Deviation 3.87 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.p-value: <0.00195% CI: [-1.38, -0.37]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.p-value: 0.13395% CI: [-0.9, 0.12]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.46, -0.37]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.p-value: 0.00395% CI: [0.38, 1.88]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.p-value: 0.46995% CI: [-0.93, 0.43]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.p-value: 0.00695% CI: [-0.98, -0.17]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.p-value: 0.00195% CI: [-6.41, -1.6]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire | -2.69 units on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire | -2.22 units on a scale | Standard Error 0.32 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.p-value: 0.25595% CI: [-1.28, 0.34]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Uric Acid
Least Squares Mean values were controlled for investigator.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Uric Acid | -14.06 Micromole/Liter | Standard Error 4.6 |
| Placebo | Change From Baseline to 12 Weeks in Uric Acid | 1.34 Micromole/Liter | Standard Error 4.64 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.p-value: 0.01ANOVA
Secondary
Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Average Pain | -2.14 units on a scale | Standard Error 0.14 |
| Duloxetine | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Worst Pain | -2.19 units on a scale | Standard Error 0.15 |
| Duloxetine | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Night Pain | -1.62 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Average Pain | -1.43 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Worst Pain | -1.48 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | Night Pain | -1.10 units on a scale | Standard Error 0.14 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.05, -0.35]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.08, -0.33]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.p-value: 0.00495% CI: [-0.87, -0.17]ANCOVA
Secondary
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. 1. Absenteeism 2. Presenteeism 3. Work productivity loss 4. Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Absenteeism, baseline; n=79, n=93 | 0.08 units on a scale | Standard Deviation 0.2 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Absenteeism, change; n=79, n=93 | -0.03 units on a scale | Standard Deviation 0.18 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Presenteeism, baseline; n=79, n=90 | 0.49 units on a scale | Standard Deviation 0.25 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Presenteeism, change; n=79, n=90 | -0.22 units on a scale | Standard Deviation 0.24 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Work Productivity Loss, baseline; n=77, n=89 | 0.50 units on a scale | Standard Deviation 0.25 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Work Productivity Loss, change; n=77, n=89 | -0.22 units on a scale | Standard Deviation 0.26 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Activity Impairment, baseline; n=190, n=196 | 0.56 units on a scale | Standard Deviation 0.22 |
| Duloxetine | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Activity Impairment, change; n=190, n=196 | -0.23 units on a scale | Standard Deviation 0.25 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Activity Impairment, change; n=190, n=196 | -0.17 units on a scale | Standard Deviation 0.21 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Absenteeism, baseline; n=79, n=93 | 0.10 units on a scale | Standard Deviation 0.25 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Work Productivity Loss, baseline; n=77, n=89 | 0.50 units on a scale | Standard Deviation 0.23 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Absenteeism, change; n=79, n=93 | -0.03 units on a scale | Standard Deviation 0.18 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Activity Impairment, baseline; n=190, n=196 | 0.56 units on a scale | Standard Deviation 0.19 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Presenteeism, baseline; n=79, n=90 | 0.48 units on a scale | Standard Deviation 0.22 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Work Productivity Loss, change; n=77, n=89 | -0.18 units on a scale | Standard Deviation 0.25 |
| Placebo | Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | Presenteeism, change; n=79, n=90 | -0.18 units on a scale | Standard Deviation 0.23 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.p-value: 0.46195% CI: [-0.03, 0.06]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.p-value: 0.37495% CI: [-0.09, 0.03]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.p-value: 0.55795% CI: [-0.09, 0.05]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.p-value: 0.00795% CI: [-0.1, -0.02]ANCOVA
Secondary
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Time frame: baseline, 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with walking ability - change | -2.23 units on a scale | Standard Deviation 2.42 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with general activity - baseline | 5.37 units on a scale | Standard Deviation 2.33 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with normal work - baseline | 5.25 units on a scale | Standard Deviation 2.33 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of least pain - baseline | 4.11 units on a scale | Standard Deviation 2.07 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with normal work - change | -2.50 units on a scale | Standard Deviation 2.44 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with general activity - change | -2.71 units on a scale | Standard Deviation 2.39 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference relations with others - baseline | 3.07 units on a scale | Standard Deviation 2.67 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of pain right now - baseline | 5.47 units on a scale | Standard Deviation 2 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference relations with others - change | -1.74 units on a scale | Standard Deviation 2.35 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with mood - baseline | 4.00 units on a scale | Standard Deviation 2.7 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with sleep - baseline | 4.74 units on a scale | Standard Deviation 2.89 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of worst pain - change | -2.75 units on a scale | Standard Deviation 2.33 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with sleep - change | -2.37 units on a scale | Standard Deviation 2.67 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with mood - change | -2.26 units on a scale | Standard Deviation 2.45 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with enjoyment of life - baseline | 4.25 units on a scale | Standard Deviation 2.84 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of pain right now - change | -2.55 units on a scale | Standard Deviation 2.27 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with enjoyment of life - change | -2.44 units on a scale | Standard Deviation 2.56 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with walking ability - baseline | 4.61 units on a scale | Standard Deviation 2.66 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI average interference - baseline | 4.44 units on a scale | Standard Deviation 2.15 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of least pain - change | -1.67 units on a scale | Standard Deviation 2.01 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI average interference - change | -2.26 units on a scale | Standard Deviation 1.96 |
| Duloxetine | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of worst pain - baseline | 7.26 units on a scale | Standard Deviation 1.52 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI average interference - change | -1.55 units on a scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of worst pain - baseline | 7.06 units on a scale | Standard Deviation 1.54 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of worst pain - change | -1.99 units on a scale | Standard Deviation 2.29 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of least pain - baseline | 4.04 units on a scale | Standard Deviation 2.03 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of least pain - change | -1.16 units on a scale | Standard Deviation 2.04 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of pain right now - baseline | 5.30 units on a scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI severity of pain right now - change | -1.65 units on a scale | Standard Deviation 2.05 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with general activity - baseline | 4.91 units on a scale | Standard Deviation 2.16 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with general activity - change | -1.71 units on a scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with mood - baseline | 3.76 units on a scale | Standard Deviation 2.54 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with mood - change | -1.41 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with walking ability - baseline | 4.13 units on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with walking ability - change | -1.52 units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with normal work - baseline | 4.91 units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with normal work - change | -1.82 units on a scale | Standard Deviation 2.22 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference relations with others - baseline | 2.82 units on a scale | Standard Deviation 2.58 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference relations with others - change | -1.04 units on a scale | Standard Deviation 2.37 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with sleep - baseline | 4.53 units on a scale | Standard Deviation 2.79 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with sleep - change | -1.55 units on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with enjoyment of life - baseline | 3.78 units on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI interference with enjoyment of life - change | -1.59 units on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | BPI average interference - baseline | 4.14 units on a scale | Standard Deviation 2.08 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.p-value: 0.00295% CI: [-1.12, -0.25]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.p-value: 0.00695% CI: [-0.85, -0.14]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.25, -0.46]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.16, -0.35]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.p-value: <0.00195% CI: [-1.09, -0.34]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.p-value: 0.0295% CI: [-0.84, -0.07]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.p-value: 0.01295% CI: [-0.9, -0.11]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.p-value: 0.00195% CI: [-0.92, -0.22]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.p-value: 0.00295% CI: [-1.13, -0.27]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.p-value: 0.00595% CI: [-0.96, -0.18]ANCOVA
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.p-value: <0.00195% CI: [-0.92, -0.25]ANCOVA
Secondary
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: 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). Number of participants under each threshold was assessed at endpoint.
Time frame: 12 weeks
Population: All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | Any Increase | 12 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | No Change | 62 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >0% Decrease | 124 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=10% Decrease | 124 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=20% Decrease | 116 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=30% Decrease | 95 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=40% Decrease | 90 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=50% Decrease | 85 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=60% Decrease | 61 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=70% Decrease | 47 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=80% Decrease | 32 participants |
| Duloxetine | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | 100% Decrease | 15 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=80% Decrease | 19 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | Any Increase | 15 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=40% Decrease | 71 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | No Change | 67 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=70% Decrease | 30 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >0% Decrease | 121 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=50% Decrease | 57 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=10% Decrease | 121 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | 100% Decrease | 11 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=20% Decrease | 106 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=60% Decrease | 38 participants |
| Placebo | Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | >=30% Decrease | 83 participants |
Comparison: Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.p-value: 0.013Kolnogorov-Smirnov test
Secondary
Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
Time frame: baseline through 12 weeks
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale | 0 participants |
| Placebo | Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale | 0 participants |
Secondary
Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is 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). Response was assessed at endpoint.
Time frame: 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 111 participants |
| Placebo | Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 97 participants |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.p-value: 0.108Fisher Exact
Secondary
Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is 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). Response was assessed at endpoint.
Time frame: 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 95 participants |
| Placebo | Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 69 participants |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.p-value: 0.006Fisher Exact
Secondary
Number of Sustained Responders at 12 Week Endpoint
Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: 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). Number of sustained responders was assessed at endpoint.
Time frame: 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Number of Sustained Responders at 12 Week Endpoint | 89 participants |
| Placebo | Number of Sustained Responders at 12 Week Endpoint | 73 participants |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.p-value: 0.082Fisher Exact
Secondary
Participants Who Discontinued From Baseline to 12 Weeks
Reasons for discontinuation are listed in the participant flow.
Time frame: baseline, 12 weeks
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Participants Who Discontinued From Baseline to 12 Weeks | 51 participants |
| Placebo | Participants Who Discontinued From Baseline to 12 Weeks | 47 participants |
Secondary
Patient's Global Impression of Improvement (PGI-I) at 12 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). Least Squares Mean values were controlled for investigator and baseline severity.
Time frame: 12 weeks
Population: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Patient's Global Impression of Improvement (PGI-I) at 12 Weeks | 2.88 units on a scale | Standard Error 0.09 |
| Placebo | Patient's Global Impression of Improvement (PGI-I) at 12 Weeks | 3.19 units on a scale | Standard Error 0.09 |
Comparison: Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.p-value: 0.01195% CI: [-0.56, -0.07]ANCOVA