Back Pain Without Radiation
Conditions
Brief summary
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Interventions
DRUGDuloxetine
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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/Female outpatients 18 years of age with chronic low back pain.
Exclusion criteria
- You have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study. - Have acute liver injury (such as hepatitis) or severe cirrhosis. - Have had previous exposure to duloxetine. - Have a body mass index (BMI) over 40. - Have major depressive disorder. - Require daily narcotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores | Baseline, Week 1 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 2 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 3 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 4 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 5 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 6 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 7 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 8 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 9 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 10 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 11 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 12 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores | Baseline, Week 13 | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People | Baseline, Week 13 | A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference | Baseline, Week 13 | 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, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | Baseline to Week 13 | — |
| Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | Baseline to Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale | Baseline, Week 13 | Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24. |
| Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) | Baseline, Week 13 | 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 \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) | Baseline, Week 13 | 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 \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain | Baseline, Week 13 | 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 \[PCS\]). Bodily pain scores range from 2-11 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health | Baseline, Week 13 | 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 \[PCS\]). General health scores range from 5-25(higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health | Baseline, Week 13 | 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 \[PCS\]). Mental health scores range from 5-30 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning | Baseline, Week 13 | 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 \[PCS\]). Physical functioning scores range from 10-30 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional | Baseline, Week 13 | 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 \[PCS\]). Role-emotional scores range from 3-6 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical | Baseline, Week 13 | 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 \[PCS\]). Role-physical scores range from 4-8 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning | Baseline, Week 13 | 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 \[PCS\]). Social functioning scores range from 2-10 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality | Baseline, Week 13 | 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 \[PCS\]). Vitality scores range from 4-24 (higher scores indicate better health status). |
| Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score | Baseline, Week 13 | The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a 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 the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. |
| Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score | Baseline, Week 13 | 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 Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | Baseline, Week 13 | 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.' |
| Adverse Events Reported as Reason for Discontinuation | Baseline to Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | Baseline, Week 13 | — |
| Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | Baseline, Week 13 | — |
| Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint | Week 13 | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score | Baseline, Week 13 | Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability). |
| Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score | Baseline, Week 13 | The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score | Baseline, Week 13 | The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain). |
| Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | Baseline, Week 13 | — |
| Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability | Baseline, Week 13 | 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 Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work | Baseline, Week 13 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine 20 mg duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks | 59 |
| Duloxetine 60 mg duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks | 116 |
| Duloxetine 120 mg duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks | 112 |
| Placebo placebo once a day (QD), by mouth (PO) for 13 weeks | 117 |
| Total | 404 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 17 | 27 | 10 |
| Overall Study | Lack of Efficacy | 2 | 4 | 5 | 6 |
| Overall Study | Lost to Follow-up | 1 | 6 | 5 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 3 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 6 | 14 |
Baseline characteristics
| Characteristic | Duloxetine 60 mg | Duloxetine 120 mg | Placebo | Total | Duloxetine 20 mg |
|---|---|---|---|---|---|
| Age Continuous | 53.32 years STANDARD_DEVIATION 14.69 | 54.92 years STANDARD_DEVIATION 14.77 | 53.97 years STANDARD_DEVIATION 13.52 | 53.89 years STANDARD_DEVIATION 14.09 | 52.93 years STANDARD_DEVIATION 12.81 |
| Beck Depression Inventory-II Total Score | 7.05 units on a scale STANDARD_DEVIATION 7.17 | 5.20 units on a scale STANDARD_DEVIATION 5 | 6.15 units on a scale STANDARD_DEVIATION 7.52 | 6.12 units on a scale STANDARD_DEVIATION 6.64 | 6.02 units on a scale STANDARD_DEVIATION 6.33 |
| Body Mass Index | 28.85 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 4.73 | 29.23 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 4.68 | 28.67 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 4.89 | 29.13 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 4.75 | 30.42 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 4.54 |
| Brief Pain Inventory (BPI) 24-Hour Average Pain Score | 5.93 units on a scale STANDARD_DEVIATION 1.67 | 6.04 units on a scale STANDARD_DEVIATION 1.63 | 6.14 units on a scale STANDARD_DEVIATION 1.66 | 6.08 units on a scale STANDARD_DEVIATION 1.65 | 6.34 units on a scale STANDARD_DEVIATION 1.64 |
| Clinical Global Impressions of Severity (CGI-S) Scale | 3.54 units on a scale STANDARD_DEVIATION 1.4 | 3.58 units on a scale STANDARD_DEVIATION 1.33 | 3.66 units on a scale STANDARD_DEVIATION 1.3 | 3.66 units on a scale STANDARD_DEVIATION 1.36 | 4.05 units on a scale STANDARD_DEVIATION 1.41 |
| Duration of Chronic Low Back Pain | 10.48 years STANDARD_DEVIATION 11.07 | 13.94 years STANDARD_DEVIATION 12.97 | 10.29 years STANDARD_DEVIATION 9.53 | 11.68 years STANDARD_DEVIATION 11.38 | 12.50 years STANDARD_DEVIATION 11.65 |
| Patient Global Impressions of Severity (PGI-S) Scale | 2.63 units on a scale STANDARD_DEVIATION 1.78 | 2.25 units on a scale STANDARD_DEVIATION 1.58 | 2.38 units on a scale STANDARD_DEVIATION 1.6 | 2.48 units on a scale STANDARD_DEVIATION 1.67 | 2.78 units on a scale STANDARD_DEVIATION 1.69 |
| Race/Ethnicity African | 11 participants | 5 participants | 10 participants | 33 participants | 7 participants |
| Race/Ethnicity Caucasian | 91 participants | 92 participants | 93 participants | 322 participants | 46 participants |
| Race/Ethnicity East Asian | 1 participants | 1 participants | 1 participants | 3 participants | 0 participants |
| Race/Ethnicity Hispanic | 13 participants | 11 participants | 11 participants | 41 participants | 6 participants |
| Race/Ethnicity Native American | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity West Asian | 0 participants | 3 participants | 1 participants | 4 participants | 0 participants |
| Region of Enrollment Argentina | 24 participants | 27 participants | 24 participants | 88 participants | 13 participants |
| Region of Enrollment United States | 92 participants | 85 participants | 93 participants | 316 participants | 46 participants |
| Roland-Morris Disability Questionnaire Total Score | 8.91 units on a scale STANDARD_DEVIATION 4.56 | 8.72 units on a scale STANDARD_DEVIATION 4.82 | 8.32 units on a scale STANDARD_DEVIATION 4.92 | 8.85 units on a scale STANDARD_DEVIATION 4.79 | 10.00 units on a scale STANDARD_DEVIATION 4.82 |
| Sex: Female, Male Female | 67 Participants | 65 Participants | 64 Participants | 232 Participants | 36 Participants |
| Sex: Female, Male Male | 49 Participants | 47 Participants | 53 Participants | 172 Participants | 23 Participants |
| Weekly Mean of 24-Hour Average Pain Severity | 6.18 units on a scale STANDARD_DEVIATION 1.44 | 6.06 units on a scale STANDARD_DEVIATION 1.45 | 6.18 units on a scale STANDARD_DEVIATION 1.25 | 6.18 units on a scale STANDARD_DEVIATION 1.38 | 6.42 units on a scale STANDARD_DEVIATION 1.39 |
| Weekly Mean of 24-Hour Worst Pain Severity | 7.22 units on a scale STANDARD_DEVIATION 1.32 | 7.22 units on a scale STANDARD_DEVIATION 1.27 | 7.35 units on a scale STANDARD_DEVIATION 1.2 | 7.29 units on a scale STANDARD_DEVIATION 1.27 | 7.41 units on a scale STANDARD_DEVIATION 1.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 59 | 78 / 116 | 80 / 112 | 69 / 117 |
| serious Total, serious adverse events | 1 / 59 | 1 / 116 | 3 / 112 | 3 / 117 |
Outcome results
Primary
Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 10
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores | -1.77 units on a scale | Standard Error 0.23 |
| Duloxetine 60 mg | Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores | -2.24 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores | -2.58 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores | -1.73 units on a scale | Standard Error 0.16 |
p-value: 0.91Repeated Measures
p-value: 0.026Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.09Repeated Measures
p-value: 0.006Repeated Measures
p-value: 0.171Repeated Measures
Primary
Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 11
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores | -1.88 units on a scale | Standard Error 0.23 |
| Duloxetine 60 mg | Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores | -2.32 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores | -2.62 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores | -1.79 units on a scale | Standard Error 0.16 |
p-value: 0.733Repeated Measures
p-value: 0.022Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.128Repeated Measures
p-value: 0.013Repeated Measures
p-value: 0.225Repeated Measures
Primary
Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 12
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores | -1.87 units on a scale | Standard Error 0.24 |
| Duloxetine 60 mg | Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores | -2.34 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores | -2.46 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores | -1.91 units on a scale | Standard Error 0.17 |
p-value: 0.89Repeated Measures
p-value: 0.079Repeated Measures
p-value: 0.035Repeated Measures
p-value: 0.117Repeated Measures
p-value: 0.06Repeated Measures
p-value: 0.647Repeated Measures
Primary
Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores | -1.74 units on a scale | Standard Error 0.25 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores | -2.50 units on a scale | Standard Error 0.18 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores | -2.42 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores | -2.10 units on a scale | Standard Error 0.18 |
p-value: 0.243Repeated Measures
p-value: 0.11Repeated Measures
p-value: 0.236Repeated Measures
p-value: 0.014Repeated Measures
p-value: 0.036Repeated Measures
p-value: 0.756Repeated Measures
Primary
Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 1
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores | -0.54 units on a scale | Standard Error 0.18 |
| Duloxetine 60 mg | Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores | -0.53 units on a scale | Standard Error 0.13 |
| Duloxetine 120 mg | Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores | -0.71 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores | -0.39 units on a scale | Standard Error 0.13 |
p-value: 0.503Repeated Measures
p-value: 0.447Repeated Measures
p-value: 0.084Repeated Measures
p-value: 0.964Repeated Measures
p-value: 0.451Repeated Measures
p-value: 0.333Repeated Measures
Primary
Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 2
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores | -0.84 units on a scale | Standard Error 0.25 |
| Duloxetine 60 mg | Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores | -0.91 units on a scale | Standard Error 0.18 |
| Duloxetine 120 mg | Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores | -1.22 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores | -0.75 units on a scale | Standard Error 0.17 |
p-value: 0.756Repeated Measures
p-value: 0.507Repeated Measures
p-value: 0.056Repeated Measures
p-value: 0.816Repeated Measures
p-value: 0.208Repeated Measures
p-value: 0.212Repeated Measures
Primary
Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 3
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores | -1.05 units on a scale | Standard Error 0.26 |
| Duloxetine 60 mg | Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores | -1.58 units on a scale | Standard Error 0.18 |
| Duloxetine 120 mg | Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores | -1.71 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores | -1.01 units on a scale | Standard Error 0.18 |
p-value: 0.885Repeated Measures
p-value: 0.026Repeated Measures
p-value: 0.007Repeated Measures
p-value: 0.095Repeated Measures
p-value: 0.04Repeated Measures
p-value: 0.635Repeated Measures
Primary
Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 4
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores | -1.20 units on a scale | Standard Error 0.26 |
| Duloxetine 60 mg | Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores | -1.70 units on a scale | Standard Error 0.18 |
| Duloxetine 120 mg | Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores | -2.17 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores | -1.02 units on a scale | Standard Error 0.18 |
p-value: 0.575Repeated Measures
p-value: 0.009Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.115Repeated Measures
p-value: 0.002Repeated Measures
p-value: 0.072Repeated Measures
Primary
Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 5
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores | -1.45 units on a scale | Standard Error 0.25 |
| Duloxetine 60 mg | Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores | -1.94 units on a scale | Standard Error 0.18 |
| Duloxetine 120 mg | Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores | -2.25 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores | -1.26 units on a scale | Standard Error 0.18 |
p-value: 0.516Repeated Measures
p-value: 0.006Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.112Repeated Measures
p-value: 0.01Repeated Measures
p-value: 0.219Repeated Measures
Primary
Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 6
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores | -1.64 units on a scale | Standard Error 0.24 |
| Duloxetine 60 mg | Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores | -2.10 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores | -2.28 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores | -1.34 units on a scale | Standard Error 0.17 |
p-value: 0.309Repeated Measures
p-value: 0.001Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.116Repeated Measures
p-value: 0.033Repeated Measures
p-value: 0.48Repeated Measures
Primary
Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 7
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores | -1.68 units on a scale | Standard Error 0.24 |
| Duloxetine 60 mg | Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores | -2.17 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores | -2.36 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores | -1.57 units on a scale | Standard Error 0.17 |
p-value: 0.709Repeated Measures
p-value: 0.012Repeated Measures
p-value: 0.001Repeated Measures
p-value: 0.097Repeated Measures
p-value: 0.023Repeated Measures
p-value: 0.435Repeated Measures
Primary
Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 8
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores | -1.68 units on a scale | Standard Error 0.24 |
| Duloxetine 60 mg | Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores | -2.29 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores | -2.49 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores | -1.65 units on a scale | Standard Error 0.17 |
p-value: 0.931Repeated Measures
p-value: 0.007Repeated Measures
p-value: <0.001Repeated Measures
p-value: 0.036Repeated Measures
p-value: 0.007Repeated Measures
p-value: 0.416Repeated Measures
Primary
Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 9
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores | -1.57 units on a scale | Standard Error 0.23 |
| Duloxetine 60 mg | Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores | -2.21 units on a scale | Standard Error 0.17 |
| Duloxetine 120 mg | Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores | -2.45 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores | -1.71 units on a scale | Standard Error 0.16 |
p-value: 0.634Repeated Measures
p-value: 0.031Repeated Measures
p-value: 0.002Repeated Measures
p-value: 0.026Repeated Measures
p-value: 0.003Repeated Measures
p-value: 0.313Repeated Measures
Secondary
Adverse Events Reported as Reason for Discontinuation
Time frame: Baseline to Week 13
Population: Number of all randomized patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Headache | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Anxiety | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Hot flush | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Loss of libido | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Hepatic enzyme increased | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Constipation | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Insomnia | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Hypertension | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Somnolence | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Hyperhidrosis | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Gastroenteritis | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Peritonsillar abscess | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Hepatitis | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Pregnancy | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Restless legs syndrome | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Testicular pain | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Palpitations | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Apathy | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Nausea | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Dysphoria | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Bursitis | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Patients Discontinued for Any Adverse Event | 9 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Irritability | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Myocardial infarction | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Confusional state | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Dizziness | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Trismus | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Glaucoma | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Coordination abnormal | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Sedation | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Rash | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Muscular weakness | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Decreased appetite | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Vomiting | 1 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Lethargy | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Disturbance in attention | 0 participants |
| Duloxetine 20 mg | Adverse Events Reported as Reason for Discontinuation | Fatigue | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Disturbance in attention | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Lethargy | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Fatigue | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Irritability | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Gastroenteritis | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Anxiety | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Glaucoma | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Headache | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Hepatitis | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Restless legs syndrome | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Hypertension | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Hot flush | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Hyperhidrosis | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Constipation | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Rash | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Dizziness | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Patients Discontinued for Any Adverse Event | 17 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Trismus | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Dysphoria | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 2 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Testicular pain | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Pregnancy | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Hepatic enzyme increased | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Peritonsillar abscess | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Somnolence | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Insomnia | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Palpitations | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Apathy | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Myocardial infarction | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Bursitis | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Nausea | 2 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Confusional state | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Muscular weakness | 1 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Coordination abnormal | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Sedation | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Decreased appetite | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Loss of libido | 0 participants |
| Duloxetine 60 mg | Adverse Events Reported as Reason for Discontinuation | Vomiting | 2 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Pregnancy | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Headache | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Patients Discontinued for Any Adverse Event | 27 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Insomnia | 3 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Nausea | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Vomiting | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Anxiety | 2 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Constipation | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Dizziness | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Hepatic enzyme increased | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Somnolence | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Apathy | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Bursitis | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Confusional state | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Coordination abnormal | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Decreased appetite | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Disturbance in attention | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Dysphoria | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Fatigue | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Gastroenteritis | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Glaucoma | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Hepatitis | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Hot flush | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Hyperhidrosis | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Hypertension | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Irritability | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Lethargy | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Loss of libido | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Muscular weakness | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Myocardial infarction | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Palpitations | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Peritonsillar abscess | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Rash | 0 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Restless legs syndrome | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Sedation | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Testicular pain | 1 participants |
| Duloxetine 120 mg | Adverse Events Reported as Reason for Discontinuation | Trismus | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Disturbance in attention | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Decreased appetite | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Headache | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Loss of libido | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Coordination abnormal | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Confusional state | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Sedation | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Muscular weakness | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Bursitis | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Apathy | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Insomnia | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Myocardial infarction | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Abdominal pain upper | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Abdominal pain | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Patients Discontinued for Any Adverse Event | 10 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Palpitations | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Somnolence | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hepatic enzyme increased | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Trismus | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Peritonsillar abscess | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Erectile dysfunction | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Dyspepsia | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Pregnancy | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Dizziness | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Diarrhoea | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Testicular pain | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Rash | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Constipation | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Anxiety | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Glaucoma | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hyperhidrosis | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hot flush | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hepatitis | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Restless legs syndrome | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Hypertension | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Gastroenteritis | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Fatigue | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Vomiting | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Irritability | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Ejaculation disorder | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Dysphoria | 0 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Nausea | 1 participants |
| Placebo | Adverse Events Reported as Reason for Discontinuation | Lethargy | 0 participants |
Secondary
Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | -1.39 Units/Liter | Standard Deviation 10.91 |
| Duloxetine 60 mg | Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | 0.25 Units/Liter | Standard Deviation 21.53 |
| Duloxetine 120 mg | Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | 2.20 Units/Liter | Standard Deviation 12.45 |
| Placebo | Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | -0.06 Units/Liter | Standard Deviation 9.48 |
p-value: 0.039t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain
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 \[PCS\]). Bodily pain scores range from 2-11 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain | 1.51 units on a scale | Standard Error 0.27 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain | 1.95 units on a scale | Standard Error 0.2 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain | 2.11 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain | 1.36 units on a scale | Standard Error 0.19 |
p-value: 0.64595% CI: [-0.49, 0.79]t-test, 2 sided
p-value: 0.02795% CI: [0.07, 1.12]t-test, 2 sided
p-value: 0.00695% CI: [0.22, 1.29]t-test, 2 sided
p-value: 0.1895% CI: [-0.21, 1.1]t-test, 2 sided
p-value: 0.06995% CI: [-0.05, 1.25]t-test, 2 sided
p-value: 0.56495% CI: [-0.38, 0.7]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health
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 \[PCS\]). General health scores range from 5-25(higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health | 0.70 units on a scale | Standard Error 0.41 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health | 1.24 units on a scale | Standard Error 0.3 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health | 0.81 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health | 0.66 units on a scale | Standard Error 0.29 |
p-value: 0.92995% CI: [-0.92, 1]t-test, 2 sided
p-value: 0.14795% CI: [-0.21, 1.36]t-test, 2 sided
p-value: 0.795% CI: [-0.64, 0.95]t-test, 2 sided
p-value: 0.27995% CI: [-0.44, 1.51]t-test, 2 sided
p-value: 0.82295% CI: [-0.86, 1.09]t-test, 2 sided
p-value: 0.29995% CI: [-1.22, 0.38]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health
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 \[PCS\]). Mental health scores range from 5-30 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health | 0.21 units on a scale | Standard Error 0.49 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health | 0.98 units on a scale | Standard Error 0.36 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health | 0.46 units on a scale | Standard Error 0.36 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health | 0.38 units on a scale | Standard Error 0.35 |
p-value: 0.76695% CI: [-1.33, 0.98]t-test, 2 sided
p-value: 0.21795% CI: [-0.35, 1.55]t-test, 2 sided
p-value: 0.8895% CI: [-0.89, 1.04]t-test, 2 sided
p-value: 0.19395% CI: [-0.39, 1.94]t-test, 2 sided
p-value: 0.67595% CI: [-0.92, 1.42]t-test, 2 sided
p-value: 0.28895% CI: [-1.5, 0.45]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)
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 \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) | 6.07 units on a scale | Standard Error 1.22 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) | 7.01 units on a scale | Standard Error 0.88 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) | 7.85 units on a scale | Standard Error 0.89 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) | 6.11 units on a scale | Standard Error 0.86 |
p-value: 0.97795% CI: [-2.91, 2.83]t-test, 2 sided
p-value: 0.45195% CI: [-1.44, 3.24]t-test, 2 sided
p-value: 0.1595% CI: [-0.63, 4.11]t-test, 2 sided
p-value: 0.52495% CI: [-1.96, 3.83]t-test, 2 sided
p-value: 0.2395% CI: [-1.13, 4.69]t-test, 2 sided
p-value: 0.49195% CI: [-1.55, 3.23]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning
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 \[PCS\]). Physical functioning scores range from 10-30 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning | 1.80 units on a scale | Standard Error 0.52 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning | 2.55 units on a scale | Standard Error 0.38 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning | 3.11 units on a scale | Standard Error 0.38 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning | 2.23 units on a scale | Standard Error 0.37 |
p-value: 0.50195% CI: [-1.66, 0.81]t-test, 2 sided
p-value: 0.52495% CI: [-0.69, 1.35]t-test, 2 sided
p-value: 0.08995% CI: [-0.14, 1.91]t-test, 2 sided
p-value: 0.23495% CI: [-0.49, 2]t-test, 2 sided
p-value: 0.0495% CI: [0.06, 2.56]t-test, 2 sided
p-value: 0.28995% CI: [-0.48, 1.59]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional
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 \[PCS\]). Role-emotional scores range from 3-6 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional | 0.10 units on a scale | Standard Error 0.12 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional | 0.19 units on a scale | Standard Error 0.09 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional | 0.14 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional | 0.08 units on a scale | Standard Error 0.09 |
p-value: 0.86295% CI: [-0.27, 0.32]t-test, 2 sided
p-value: 0.36895% CI: [-0.13, 0.35]t-test, 2 sided
p-value: 0.62895% CI: [-0.18, 0.31]t-test, 2 sided
p-value: 0.57395% CI: [-0.21, 0.38]t-test, 2 sided
p-value: 0.81995% CI: [-0.26, 0.33]t-test, 2 sided
p-value: 0.68795% CI: [-0.3, 0.2]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical
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 \[PCS\]). Role-physical scores range from 4-8 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical | 0.81 units on a scale | Standard Error 0.21 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical | 0.80 units on a scale | Standard Error 0.15 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical | 0.85 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical | 0.80 units on a scale | Standard Error 0.15 |
p-value: 0.97295% CI: [-0.48, 0.5]t-test, 2 sided
p-value: 0.9995% CI: [-0.4, 0.4]t-test, 2 sided
p-value: 0.79395% CI: [-0.35, 0.46]t-test, 2 sided
p-value: 0.98195% CI: [-0.5, 0.49]t-test, 2 sided
p-value: 0.85795% CI: [-0.45, 0.54]t-test, 2 sided
p-value: 0.80595% CI: [-0.36, 0.46]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning
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 \[PCS\]). Social functioning scores range from 2-10 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning | 0.75 units on a scale | Standard Error 0.21 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning | 0.46 units on a scale | Standard Error 0.16 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning | 0.38 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning | 0.50 units on a scale | Standard Error 0.15 |
p-value: 0.3495% CI: [-0.26, 0.75]t-test, 2 sided
p-value: 0.84895% CI: [-0.45, 0.37]t-test, 2 sided
p-value: 0.57395% CI: [-0.54, 0.3]t-test, 2 sided
p-value: 0.27295% CI: [-0.79, 0.22]t-test, 2 sided
p-value: 0.16195% CI: [-0.88, 0.15]t-test, 2 sided
p-value: 0.71195% CI: [-0.5, 0.34]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality
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 \[PCS\]). Vitality scores range from 4-24 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality | 0.69 units on a scale | Standard Error 0.5 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality | 1.43 units on a scale | Standard Error 0.36 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality | 0.44 units on a scale | Standard Error 0.37 |
| Placebo | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality | 0.91 units on a scale | Standard Error 0.35 |
p-value: 0.71395% CI: [-1.39, 0.95]t-test, 2 sided
p-value: 0.28895% CI: [-0.44, 1.49]t-test, 2 sided
p-value: 0.35195% CI: [-1.44, 0.51]t-test, 2 sided
p-value: 0.21995% CI: [-0.44, 1.93]t-test, 2 sided
p-value: 0.68695% CI: [-1.43, 0.94]t-test, 2 sided
p-value: 0.0595% CI: [-1.97, 0]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale | -1.43 units on a scale | Standard Error 0.53 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale | -2.30 units on a scale | Standard Error 0.39 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale | -0.93 units on a scale | Standard Error 0.4 |
| Placebo | Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale | -1.23 units on a scale | Standard Error 0.38 |
p-value: 0.74795% CI: [-1.47, 1.06]t-test, 2 sided
p-value: 0.04595% CI: [-2.12, -0.02]t-test, 2 sided
p-value: 0.5895% CI: [-0.76, 1.36]t-test, 2 sided
p-value: 0.18595% CI: [-2.14, 0.41]t-test, 2 sided
p-value: 0.43895% CI: [-0.77, 1.79]t-test, 2 sided
p-value: 0.01295% CI: [0.3, 2.44]t-test, 2 sided
Secondary
Change From Baseline to Week 13 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score | -1.24 units on a scale | Standard Error 0.68 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score | -1.54 units on a scale | Standard Error 0.5 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score | 0.37 units on a scale | Standard Error 0.5 |
| Placebo | Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score | -1.02 units on a scale | Standard Error 0.49 |
p-value: 0.78695% CI: [-1.83, 1.39]t-test, 2 sided
p-value: 0.44595% CI: [-1.85, 0.81]t-test, 2 sided
p-value: 0.04395% CI: [0.04, 2.74]t-test, 2 sided
p-value: 0.72195% CI: [-1.92, 1.33]t-test, 2 sided
p-value: 0.05395% CI: [-0.02, 3.24]t-test, 2 sided
p-value: 0.00695% CI: [0.54, 3.27]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference | -1.84 units on a scale | Standard Error 0.26 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference | -2.40 units on a scale | Standard Error 0.19 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference | -1.92 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference | -1.61 units on a scale | Standard Error 0.19 |
p-value: 0.46595% CI: [-0.84, 0.39]t-test, 2 sided
p-value: 0.00295% CI: [-1.3, -0.29]t-test, 2 sided
p-value: 0.23395% CI: [-0.82, 0.2]t-test, 2 sided
p-value: 0.07595% CI: [-1.19, 0.06]t-test, 2 sided
p-value: 0.79895% CI: [-0.71, 0.54]t-test, 2 sided
p-value: 0.06695% CI: [-0.03, 1]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life | -1.84 units on a scale | Standard Error 0.32 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life | -2.49 units on a scale | Standard Error 0.24 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life | -1.86 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life | -1.76 units on a scale | Standard Error 0.23 |
p-value: 0.84995% CI: [-0.84, 0.69]t-test, 2 sided
p-value: 0.02495% CI: [-1.36, -0.1]t-test, 2 sided
p-value: 0.77395% CI: [-0.73, 0.54]t-test, 2 sided
p-value: 0.09795% CI: [-1.43, 0.12]t-test, 2 sided
p-value: 0.9695% CI: [-0.79, 0.75]t-test, 2 sided
p-value: 0.05295% CI: [0, 1.28]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity | -1.99 units on a scale | Standard Error 0.33 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity | -2.52 units on a scale | Standard Error 0.24 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity | -2.36 units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity | -1.97 units on a scale | Standard Error 0.24 |
p-value: 0.94895% CI: [-0.81, 0.76]t-test, 2 sided
p-value: 0.09695% CI: [-1.2, 0.1]t-test, 2 sided
p-value: 0.23995% CI: [-1.05, 0.26]t-test, 2 sided
p-value: 0.19695% CI: [-1.32, 0.27]t-test, 2 sided
p-value: 0.36795% CI: [-1.17, 0.43]t-test, 2 sided
p-value: 0.63795% CI: [-0.5, 0.82]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood | -1.75 units on a scale | Standard Error 0.3 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood | -2.52 units on a scale | Standard Error 0.22 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood | -1.96 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood | -1.70 units on a scale | Standard Error 0.21 |
p-value: 0.88795% CI: [-0.76, 0.65]t-test, 2 sided
p-value: 0.00695% CI: [-1.4, -0.23]t-test, 2 sided
p-value: 0.39295% CI: [-0.84, 0.33]t-test, 2 sided
p-value: 0.03695% CI: [-1.48, -0.05]t-test, 2 sided
p-value: 0.57395% CI: [-0.92, 0.51]t-test, 2 sided
p-value: 0.06495% CI: [-0.03, 1.15]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work | -2.20 units on a scale | Standard Error 0.36 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work | -2.67 units on a scale | Standard Error 0.26 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work | -2.38 units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work | -1.95 units on a scale | Standard Error 0.26 |
p-value: 0.55695% CI: [-1.1, 0.59]t-test, 2 sided
p-value: 0.04195% CI: [-1.42, -0.03]t-test, 2 sided
p-value: 0.2295% CI: [-1.14, 0.26]t-test, 2 sided
p-value: 0.27895% CI: [-1.33, 0.38]t-test, 2 sided
p-value: 0.67395% CI: [-1.04, 0.68]t-test, 2 sided
p-value: 0.42295% CI: [-0.42, 1]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People | -1.33 units on a scale | Standard Error 0.27 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People | -1.86 units on a scale | Standard Error 0.2 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People | -1.27 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People | -0.94 units on a scale | Standard Error 0.19 |
p-value: 0.23495% CI: [-1.03, 0.25]t-test, 2 sided
p-value: <0.00195% CI: [-1.46, -0.4]t-test, 2 sided
p-value: 0.21395% CI: [-0.87, 0.2]t-test, 2 sided
p-value: 0.10595% CI: [-1.19, 0.11]t-test, 2 sided
p-value: 0.87695% CI: [-0.6, 0.7]t-test, 2 sided
p-value: 0.03395% CI: [0.05, 1.13]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep | -1.59 units on a scale | Standard Error 0.32 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep | -2.48 units on a scale | Standard Error 0.24 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep | -2.12 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep | -1.63 units on a scale | Standard Error 0.23 |
p-value: 0.92595% CI: [-0.73, 0.8]t-test, 2 sided
p-value: 0.00895% CI: [-1.49, -0.22]t-test, 2 sided
p-value: 0.13295% CI: [-1.12, 0.15]t-test, 2 sided
p-value: 0.02495% CI: [-1.67, -0.12]t-test, 2 sided
p-value: 0.18495% CI: [-1.3, 0.25]t-test, 2 sided
p-value: 0.26295% CI: [-0.27, 1.01]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability | -1.79 units on a scale | Standard Error 0.34 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability | -2.33 units on a scale | Standard Error 0.25 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability | -1.89 units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability | -1.43 units on a scale | Standard Error 0.24 |
p-value: 0.37495% CI: [-1.15, 0.43]t-test, 2 sided
p-value: 0.00795% CI: [-1.55, -0.25]t-test, 2 sided
p-value: 0.16995% CI: [-1.12, 0.2]t-test, 2 sided
p-value: 0.18295% CI: [-1.35, 0.26]t-test, 2 sided
p-value: 0.80295% CI: [-0.91, 0.7]t-test, 2 sided
p-value: 0.19195% CI: [-0.22, 1.11]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | -1.79 units on a scale | Standard Error 0.3 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | -2.50 units on a scale | Standard Error 0.22 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | -2.45 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | -1.87 units on a scale | Standard Error 0.22 |
p-value: 0.81395% CI: [-0.63, 0.8]t-test, 2 sided
p-value: 0.03595% CI: [-1.21, -0.04]t-test, 2 sided
p-value: 0.05495% CI: [-1.17, 0.01]t-test, 2 sided
p-value: 0.05195% CI: [-1.43, 0]t-test, 2 sided
p-value: 0.0795% CI: [-1.39, 0.05]t-test, 2 sided
p-value: 0.87295% CI: [-0.54, 0.64]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score | -1.30 units on a scale | Standard Error 0.29 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score | -2.06 units on a scale | Standard Error 0.21 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score | -2.16 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score | -1.51 units on a scale | Standard Error 0.2 |
p-value: 0.54395% CI: [-0.46, 0.88]t-test, 2 sided
p-value: 0.05395% CI: [-1.1, 0.01]t-test, 2 sided
p-value: 0.02495% CI: [-1.21, -0.09]t-test, 2 sided
p-value: 0.0395% CI: [-1.43, -0.07]t-test, 2 sided
p-value: 0.01495% CI: [-1.54, -0.17]t-test, 2 sided
p-value: 0.72795% CI: [-0.66, 0.46]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score | -1.63 units on a scale | Standard Error 0.33 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score | -2.67 units on a scale | Standard Error 0.24 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score | -2.61 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score | -1.74 units on a scale | Standard Error 0.24 |
p-value: 0.7995% CI: [-0.68, 0.89]t-test, 2 sided
p-value: 0.00595% CI: [-1.57, -0.28]t-test, 2 sided
p-value: 0.00995% CI: [-1.52, -0.22]t-test, 2 sided
p-value: 0.01195% CI: [-1.83, -0.24]t-test, 2 sided
p-value: 0.01695% CI: [-1.77, -0.18]t-test, 2 sided
p-value: 0.85795% CI: [-0.6, 0.72]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score | -1.78 units on a scale | Standard Error 0.35 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score | -2.77 units on a scale | Standard Error 0.25 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score | -2.78 units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score | -2.09 units on a scale | Standard Error 0.25 |
p-value: 0.46495% CI: [-0.52, 1.14]t-test, 2 sided
p-value: 0.05295% CI: [-1.36, 0]t-test, 2 sided
p-value: 0.05295% CI: [-1.37, 0.01]t-test, 2 sided
p-value: 0.02195% CI: [-1.83, -0.15]t-test, 2 sided
p-value: 0.0295% CI: [-1.83, -0.16]t-test, 2 sided
p-value: 0.98895% CI: [-0.7, 0.69]t-test, 2 sided
Secondary
Change From Baseline to Week 13 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity | -0.53 units on a scale | Standard Error 0.14 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity | -0.94 units on a scale | Standard Error 0.11 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity | -1.06 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity | -0.53 units on a scale | Standard Error 0.1 |
p-value: 0.98495% CI: [-0.34, 0.34]t-test, 2 sided
p-value: 0.00495% CI: [-0.7, -0.13]t-test, 2 sided
p-value: <0.00195% CI: [-0.81, -0.24]t-test, 2 sided
p-value: 0.01895% CI: [-0.76, -0.07]t-test, 2 sided
p-value: 0.00395% CI: [-0.87, -0.19]t-test, 2 sided
p-value: 0.44295% CI: [-0.4, 0.17]t-test, 2 sided
Secondary
Change From Baseline to Week 13 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, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | -0.30 units on a scale | Standard Error 0.36 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | -0.81 units on a scale | Standard Error 0.27 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | -0.91 units on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | -0.68 units on a scale | Standard Error 0.26 |
p-value: 0.37895% CI: [-0.48, 1.25]t-test, 2 sided
p-value: 0.72395% CI: [-0.84, 0.59]t-test, 2 sided
p-value: 0.54295% CI: [-0.95, 0.5]t-test, 2 sided
p-value: 0.24595% CI: [-1.39, 0.36]t-test, 2 sided
p-value: 0.16995% CI: [-1.48, 0.26]t-test, 2 sided
p-value: 0.79695% CI: [-0.82, 0.63]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | 1.04 millimole/Liter | Standard Deviation 3.29 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | 1.18 millimole/Liter | Standard Deviation 3.6 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | 1.72 millimole/Liter | Standard Deviation 2.93 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | 1.35 millimole/Liter | Standard Deviation 3.09 |
p-value: 0.048t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | -0.29 micromole/Liter | Standard Deviation 0.68 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | -0.13 micromole/Liter | Standard Deviation 0.82 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | -0.13 micromole/Liter | Standard Deviation 0.74 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | 0.07 micromole/Liter | Standard Deviation 0.82 |
p-value: 0.015t-test, 2 sided
p-value: 0.046t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | -1.05 micromole/Liter | Standard Deviation 2.56 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | -0.23 micromole/Liter | Standard Deviation 3.5 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | -0.58 micromole/Liter | Standard Deviation 2.57 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | 0.18 micromole/Liter | Standard Deviation 3.15 |
p-value: 0.039t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | -0.22 millimole/Liter | Standard Deviation 2.44 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | -0.54 millimole/Liter | Standard Deviation 2.81 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | -0.99 millimole/Liter | Standard Deviation 2.55 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | -0.47 millimole/Liter | Standard Deviation 2.48 |
p-value: 0.042t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | -0.04 millimole/Liter | Standard Deviation 0.74 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | -0.09 millimole/Liter | Standard Deviation 0.7 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | 0.01 millimole/Liter | Standard Deviation 0.88 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | -0.22 millimole/Liter | Standard Deviation 0.62 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | -11.43 micromole/Liter | Standard Deviation 89.68 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | -0.66 micromole/Liter | Standard Deviation 8.96 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | 1.34 micromole/Liter | Standard Deviation 9.91 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | 2.02 micromole/Liter | Standard Deviation 10.36 |
p-value: 0.031t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | -0.02 millimole/Liter | Standard Deviation 0.41 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | 0.00 millimole/Liter | Standard Deviation 0.42 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | 0.06 millimole/Liter | Standard Deviation 0.44 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | -0.08 millimole/Liter | Standard Deviation 0.42 |
p-value: 0.03t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | -1.19 Units/Liter | Standard Deviation 11.19 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | 3.27 Units/Liter | Standard Deviation 14.17 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | 1.11 Units/Liter | Standard Deviation 12.37 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | -1.43 Units/Liter | Standard Deviation 7.61 |
p-value: <0.001t-test, 2 sided
p-value: 0.015t-test, 2 sided
p-value: 0.015t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | -9.48 micromole/Liter | Standard Deviation 45.82 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | -11.08 micromole/Liter | Standard Deviation 49.35 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | -11.31 micromole/Liter | Standard Deviation 50.54 |
| Placebo | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | 8.20 micromole/Liter | Standard Deviation 37.89 |
p-value: 0.005t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.001t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score
Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -2.29 units on a scale | Standard Error 0.56 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -2.74 units on a scale | Standard Error 0.44 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -2.88 units on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -1.33 units on a scale | Standard Error 0.43 |
p-value: 0.16195% CI: [-2.32, 0.39]t-test, 2 sided
p-value: 0.01995% CI: [-2.59, -0.24]t-test, 2 sided
p-value: 0.0195% CI: [-2.74, -0.38]t-test, 2 sided
p-value: 0.52695% CI: [-1.83, 0.94]t-test, 2 sided
p-value: 0.39795% CI: [-1.96, 0.78]t-test, 2 sided
p-value: 0.81395% CI: [-1.35, 1.06]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score
The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score | -1.77 units on a scale | Standard Error 0.27 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score | -2.15 units on a scale | Standard Error 0.2 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score | -2.47 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score | -1.91 units on a scale | Standard Error 0.19 |
p-value: 0.65795% CI: [-0.5, 0.79]t-test, 2 sided
p-value: 0.38495% CI: [-0.76, 0.29]t-test, 2 sided
p-value: 0.0495% CI: [-1.1, -0.03]t-test, 2 sided
p-value: 0.25395% CI: [-1.03, 0.27]t-test, 2 sided
p-value: 0.03495% CI: [-1.36, -0.05]t-test, 2 sided
p-value: 0.23295% CI: [-0.86, 0.21]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score
The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score | -1.77 units on a scale | Standard Error 0.3 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score | -2.46 units on a scale | Standard Error 0.22 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score | -2.40 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score | -2.10 units on a scale | Standard Error 0.22 |
p-value: 0.36595% CI: [-0.39, 1.05]t-test, 2 sided
p-value: 0.23295% CI: [-0.95, 0.23]t-test, 2 sided
p-value: 0.31495% CI: [-0.9, 0.29]t-test, 2 sided
p-value: 0.06295% CI: [-1.41, 0.03]t-test, 2 sided
p-value: 0.08395% CI: [-1.36, 0.08]t-test, 2 sided
p-value: 0.85995% CI: [-0.54, 0.65]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)
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 \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) | 0.01 units on a scale | Standard Error 1.11 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) | 0.57 units on a scale | Standard Error 0.81 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) | -1.26 units on a scale | Standard Error 0.82 |
| Placebo | Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) | -0.45 units on a scale | Standard Error 0.79 |
p-value: 0.72995% CI: [-2.16, 3.08]t-test, 2 sided
p-value: 0.35295% CI: [-1.14, 3.18]t-test, 2 sided
p-value: 0.46595% CI: [-3, 1.37]t-test, 2 sided
p-value: 0.67795% CI: [-2.09, 3.21]t-test, 2 sided
p-value: 0.34595% CI: [-3.92, 1.38]t-test, 2 sided
p-value: 0.10295% CI: [-4.04, 0.37]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a 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 the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score | 0.04 units on a scale | Standard Error 0.02 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score | 0.07 units on a scale | Standard Error 0.01 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score | 0.08 units on a scale | Standard Error 0.02 |
| Placebo | Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score | 0.05 units on a scale | Standard Error 0.01 |
p-value: 0.66395% CI: [-0.06, 0.04]t-test, 2 sided
p-value: 0.3395% CI: [-0.02, 0.06]t-test, 2 sided
p-value: 0.14395% CI: [-0.01, 0.07]t-test, 2 sided
p-value: 0.21895% CI: [-0.02, 0.08]t-test, 2 sided
p-value: 0.195% CI: [-0.01, 0.09]t-test, 2 sided
p-value: 0.61495% CI: [-0.03, 0.05]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | -0.51 mm Hg | Standard Error 1.14 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | -0.79 mm Hg | Standard Error 0.84 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | 2.94 mm Hg | Standard Error 0.85 |
| Placebo | Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | -0.68 mm Hg | Standard Error 0.82 |
p-value: 0.90195% CI: [-2.54, 2.89]t-test, 2 sided
p-value: 0.92695% CI: [-2.35, 2.14]t-test, 2 sided
p-value: 0.00295% CI: [1.35, 5.9]t-test, 2 sided
p-value: 0.84195% CI: [-3.02, 2.46]t-test, 2 sided
p-value: 0.01495% CI: [0.71, 6.19]t-test, 2 sided
p-value: 0.00195% CI: [1.44, 6.02]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | -1.10 beats per minute | Standard Error 1.21 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | 2.79 beats per minute | Standard Error 0.89 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | 1.90 beats per minute | Standard Error 0.9 |
| Placebo | Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | 0.29 beats per minute | Standard Error 0.87 |
p-value: 0.34895% CI: [-4.28, 1.51]t-test, 2 sided
p-value: 0.0495% CI: [0.11, 4.89]t-test, 2 sided
p-value: 0.19195% CI: [-0.81, 4.03]t-test, 2 sided
p-value: 0.00995% CI: [0.97, 6.8]t-test, 2 sided
p-value: 0.04495% CI: [0.08, 5.91]t-test, 2 sided
p-value: 0.47395% CI: [-3.33, 1.55]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | -0.64 mm Hg | Standard Error 1.68 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | -1.18 mm Hg | Standard Error 1.24 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | 1.00 mm Hg | Standard Error 1.25 |
| Placebo | Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | -1.04 mm Hg | Standard Error 1.21 |
p-value: 0.84695% CI: [-3.61, 4.4]t-test, 2 sided
p-value: 0.93495% CI: [-3.45, 3.17]t-test, 2 sided
p-value: 0.23495% CI: [-1.32, 5.39]t-test, 2 sided
p-value: 0.79495% CI: [-4.58, 3.5]t-test, 2 sided
p-value: 0.42695% CI: [-2.4, 5.67]t-test, 2 sided
p-value: 0.20795% CI: [-1.21, 5.55]t-test, 2 sided
Secondary
Change From Baseline to Week 13 Endpoint in Vital Signs - Weight
Time frame: Baseline, Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | -0.59 kilograms | Standard Error 0.3 |
| Duloxetine 60 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | -0.35 kilograms | Standard Error 0.22 |
| Duloxetine 120 mg | Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | -0.72 kilograms | Standard Error 0.22 |
| Placebo | Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | 0.10 kilograms | Standard Error 0.22 |
p-value: 0.05795% CI: [-1.41, 0.02]t-test, 2 sided
p-value: 0.12895% CI: [-1.05, 0.13]t-test, 2 sided
p-value: 0.00795% CI: [-1.42, -0.22]t-test, 2 sided
p-value: 0.51895% CI: [-0.48, 0.96]t-test, 2 sided
p-value: 0.73495% CI: [-0.85, 0.6]t-test, 2 sided
p-value: 0.23995% CI: [-0.97, 0.24]t-test, 2 sided
Secondary
Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 20 mg | Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint | 2.72 units on a scale | Standard Error 0.17 |
| Duloxetine 60 mg | Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint | 2.44 units on a scale | Standard Error 0.13 |
| Duloxetine 120 mg | Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint | 2.66 units on a scale | Standard Error 0.13 |
| Placebo | Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint | 2.93 units on a scale | Standard Error 0.13 |
p-value: 0.31895% CI: [-0.62, 0.2]t-test, 2 sided
p-value: 0.00595% CI: [-0.83, -0.15]t-test, 2 sided
p-value: 0.12495% CI: [-0.61, 0.07]t-test, 2 sided
p-value: 0.18395% CI: [-0.7, 0.13]t-test, 2 sided
p-value: 0.77895% CI: [-0.48, 0.36]t-test, 2 sided
p-value: 0.2195% CI: [-0.13, 0.57]t-test, 2 sided
Secondary
Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
Time frame: Baseline to Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine 20 mg | Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 23 participants |
| Duloxetine 60 mg | Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 59 participants |
| Duloxetine 120 mg | Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 63 participants |
| Placebo | Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 49 participants |
p-value: 0.869Fisher Exact
p-value: 0.141Fisher Exact
p-value: 0.033Fisher Exact
p-value: 0.142Fisher Exact
p-value: 0.049Fisher Exact
p-value: 0.587Fisher Exact
Secondary
Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
Time frame: Baseline to Week 13
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine 20 mg | Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 12 participants |
| Duloxetine 60 mg | Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 38 participants |
| Duloxetine 120 mg | Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 40 participants |
| Placebo | Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward | 33 participants |
p-value: 0.356Fisher Exact
p-value: 0.472Fisher Exact
p-value: 0.255Fisher Exact
p-value: 0.107Fisher Exact
p-value: 0.053Fisher Exact
p-value: 0.779Fisher Exact