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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMEO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine 20 mg | Experimental | duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks |
|
| Duloxetine 60 mg | Experimental | duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks |
|
| Duloxetine 120 mg | Experimental | 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 |
|
| Placebo | Placebo Comparator | placebo once a day (QD), by mouth (PO) for 13 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 1 |
| 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). | Baseline, Week 2 |
| 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). | Baseline, Week 3 |
| 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). | Baseline, Week 4 |
| 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). | Baseline, Week 5 |
| Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 13 |
| Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | Fort Myers | Florida | 33912 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24650448 | Derived | Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine 20 mg | duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Placebo | placebo once a day (QD), by mouth (PO) for 13 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine 20 mg | duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine 20 mg | duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug |
|
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).
| Baseline, Week 6 |
| 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). | Baseline, Week 7 |
| 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). | Baseline, Week 8 |
| 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). | Baseline, Week 9 |
| 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). | Baseline, Week 10 |
| 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). | Baseline, Week 11 |
| 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). | Baseline, Week 12 |
| 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). | 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). |
| Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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 | 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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 | 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. | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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). | Baseline, Week 13 |
| 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. | Baseline, Week 13 |
| 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. | Baseline, Week 13 |
| 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.' | Baseline, Week 13 |
| 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 |
| Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | Baseline, Week 13 |
| 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 |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | Orlando | Florida | 32806 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | South Miami | Florida | 33143 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | Tampa | Florida | 33606 | United States |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Physician Decision |
|
| BG002 | 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 |
| BG003 | Placebo | placebo once a day (QD), by mouth (PO) for 13 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meters (kg/m^2) |
|
| Brief Pain Inventory (BPI) 24-Hour Average Pain Score | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impressions of Severity (CGI-S) Scale | 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). | Mean | Standard Deviation | units on a scale |
|
| Duration of Chronic Low Back Pain | Mean | Standard Deviation | years |
|
| Patient Global Impressions of Severity (PGI-S) Scale | Measures patient's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill ). | Mean | Standard Deviation | units on a scale |
|
| Roland-Morris Disability Questionnaire 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). | Mean | Standard Deviation | units on a scale |
|
| Weekly Mean of 24-Hour Average Pain Severity | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). | Mean | Standard Deviation | units on a scale |
|
| Weekly Mean of 24-Hour Worst Pain Severity | 24-hour worst pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). | Mean | Standard Deviation | units on a scale |
|
| OG002 | 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 |
| OG003 | Placebo | placebo once a day (QD), by mouth (PO) for 13 weeks |
|
|
|
| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 13 |
|
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 2 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 3 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 4 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 5 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 6 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 7 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 8 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 9 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 10 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 11 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| 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). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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 | 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. | Posted | Number | participants | Baseline to Week 13 |
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| 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 | 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. | Posted | Number | participants | Baseline to Week 13 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| 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.' | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
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| Secondary | Adverse Events Reported as Reason for Discontinuation | Number of all randomized patients. | Posted | Number | participants | Baseline to Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase | 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. | Posted | Mean | Standard Deviation | Units/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase | 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. | Posted | Mean | Standard Deviation | Units/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 | 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. | Posted | Mean | Standard Deviation | millimole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct | 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. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total | 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. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride | 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. | Posted | Mean | Standard Deviation | millimole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol | 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. | Posted | Mean | Standard Deviation | millimole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine | 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. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium | 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. | Posted | Mean | Standard Deviation | millimole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid | 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. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate | 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. | Posted | Least Squares Mean | Standard Error | beats per minute | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure | 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. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure | 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. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 13 |
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| Secondary | Change From Baseline to Week 13 Endpoint in Vital Signs - Weight | 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. | Posted | Least Squares Mean | Standard Error | kilograms | Baseline, Week 13 |
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| 1 |
| 59 |
| 39 |
| 59 |
| EG001 | 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 | 1 | 116 | 78 | 116 |
| EG002 | 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 | 3 | 112 | 80 | 112 |
| EG003 | Placebo | placebo once a day (QD), by mouth (PO) for 13 weeks | 3 | 117 | 69 | 117 |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Therapeutic response unexpected | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Neurological examination abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anorgasmia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Loss of libido | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |
| Mean Difference (Net) |
| -0.49 |
| 95 |
| -0.83 |
| -0.15 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.124 | Mean Difference (Net) | -0.27 | 95 | -0.61 | 0.07 | No | Superiority or Other |
| t-test, 2 sided | 0.183 | Mean Difference (Net) | -0.28 | 95 | -0.70 | 0.13 | No | Superiority or Other |
| t-test, 2 sided | 0.778 | Mean Difference (Net) | -0.06 | 95 | -0.48 | 0.36 | No | Superiority or Other |
| t-test, 2 sided | 0.210 | Mean Difference (Net) | 0.22 | 95 | -0.13 | 0.57 | No | Superiority or Other |
| Mean Difference (Net) |
| -1.41 |
| 95 |
| -2.59 |
| -0.24 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.010 | Mean Difference (Net) | -1.56 | 95 | -2.74 | -0.38 | No | Superiority or Other |
| t-test, 2 sided | 0.526 | Mean Difference (Net) | -0.45 | 95 | -1.83 | 0.94 | No | Superiority or Other |
| t-test, 2 sided | 0.397 | Mean Difference (Net) | -0.59 | 95 | -1.96 | 0.78 | No | Superiority or Other |
| t-test, 2 sided | 0.813 | Mean Difference (Net) | -0.15 | 95 | -1.35 | 1.06 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.23 |
| 95 |
| -0.76 |
| 0.29 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.040 | Mean Difference (Net) | -0.56 | 95 | -1.10 | -0.03 | No | Superiority or Other |
| t-test, 2 sided | 0.253 | Mean Difference (Net) | -0.38 | 95 | -1.03 | 0.27 | No | Superiority or Other |
| t-test, 2 sided | 0.034 | Mean Difference (Net) | -0.71 | 95 | -1.36 | -0.05 | No | Superiority or Other |
| t-test, 2 sided | 0.232 | Mean Difference (Net) | -0.33 | 95 | -0.86 | 0.21 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.36 |
| 95 |
| -0.95 |
| 0.23 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.314 | Mean Difference (Net) | -0.30 | 95 | -0.90 | 0.29 | No | Superiority or Other |
| t-test, 2 sided | 0.062 | Mean Difference (Net) | -0.69 | 95 | -1.41 | 0.03 | No | Superiority or Other |
| t-test, 2 sided | 0.083 | Mean Difference (Net) | -0.64 | 95 | -1.36 | 0.08 | No | Superiority or Other |
| t-test, 2 sided | 0.859 | Mean Difference (Net) | 0.05 | 95 | -0.54 | 0.65 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.41 |
| 95 |
| -0.70 |
| -0.13 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.001 | Mean Difference (Net) | -0.53 | 95 | -0.81 | -0.24 | No | Superiority or Other |
| t-test, 2 sided | 0.018 | Mean Difference (Net) | -0.42 | 95 | -0.76 | -0.07 | No | Superiority or Other |
| t-test, 2 sided | 0.003 | Mean Difference (Net) | -0.53 | 95 | -0.87 | -0.19 | No | Superiority or Other |
| t-test, 2 sided | 0.442 | Mean Difference (Net) | -0.11 | 95 | -0.40 | 0.17 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.68 |
| 95 |
| -1.36 |
| 0.00 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.052 | Mean Difference (Net) | -0.68 | 95 | -1.37 | 0.01 | No | Superiority or Other |
| t-test, 2 sided | 0.021 | Mean Difference (Net) | -0.99 | 95 | -1.83 | -0.15 | No | Superiority or Other |
| t-test, 2 sided | 0.020 | Mean Difference (Net) | -0.99 | 95 | -1.83 | -0.16 | No | Superiority or Other |
| t-test, 2 sided | 0.988 | Mean Difference (Net) | -0.01 | 95 | -0.70 | 0.69 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.55 |
| 95 |
| -1.10 |
| 0.01 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.024 | Mean Difference (Net) | -0.65 | 95 | -1.21 | -0.09 | No | Superiority or Other |
| t-test, 2 sided | 0.030 | Mean Difference (Net) | -0.75 | 95 | -1.43 | -0.07 | No | Superiority or Other |
| t-test, 2 sided | 0.014 | Mean Difference (Net) | -0.85 | 95 | -1.54 | -0.17 | No | Superiority or Other |
| t-test, 2 sided | 0.727 | Mean Difference (Net) | -0.10 | 95 | -0.66 | 0.46 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.63 |
| 95 |
| -1.21 |
| -0.04 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.054 | Mean Difference (Net) | -0.58 | 95 | -1.17 | 0.01 | No | Superiority or Other |
| t-test, 2 sided | 0.051 | Mean Difference (Net) | -0.71 | 95 | -1.43 | 0.00 | No | Superiority or Other |
| t-test, 2 sided | 0.070 | Mean Difference (Net) | -0.67 | 95 | -1.39 | 0.05 | No | Superiority or Other |
| t-test, 2 sided | 0.872 | Mean Difference (Net) | 0.05 | 95 | -0.54 | 0.64 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.93 |
| 95 |
| -1.57 |
| -0.28 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.009 | Mean Difference (Net) | -0.87 | 95 | -1.52 | -0.22 | No | Superiority or Other |
| t-test, 2 sided | 0.011 | Mean Difference (Net) | -1.03 | 95 | -1.83 | -0.24 | No | Superiority or Other |
| t-test, 2 sided | 0.016 | Mean Difference (Net) | -0.97 | 95 | -1.77 | -0.18 | No | Superiority or Other |
| t-test, 2 sided | 0.857 | Mean Difference (Net) | 0.06 | 95 | -0.60 | 0.72 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.55 |
| 95 |
| -1.20 |
| 0.10 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.239 | Mean Difference (Net) | -0.39 | 95 | -1.05 | 0.26 | No | Superiority or Other |
| t-test, 2 sided | 0.196 | Mean Difference (Net) | -0.53 | 95 | -1.32 | 0.27 | No | Superiority or Other |
| t-test, 2 sided | 0.367 | Mean Difference (Net) | -0.37 | 95 | -1.17 | 0.43 | No | Superiority or Other |
| t-test, 2 sided | 0.637 | Mean Difference (Net) | 0.16 | 95 | -0.50 | 0.82 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.81 |
| 95 |
| -1.40 |
| -0.23 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.392 | Mean Difference (Net) | -0.26 | 95 | -0.84 | 0.33 | No | Superiority or Other |
| t-test, 2 sided | 0.036 | Mean Difference (Net) | -0.76 | 95 | -1.48 | -0.05 | No | Superiority or Other |
| t-test, 2 sided | 0.573 | Mean Difference (Net) | -0.20 | 95 | -0.92 | 0.51 | No | Superiority or Other |
| t-test, 2 sided | 0.064 | Mean Difference (Net) | 0.56 | 95 | -0.03 | 1.15 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.90 |
| 95 |
| -1.55 |
| -0.25 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.169 | Mean Difference (Net) | -0.46 | 95 | -1.12 | 0.20 | No | Superiority or Other |
| t-test, 2 sided | 0.182 | Mean Difference (Net) | -0.54 | 95 | -1.35 | 0.26 | No | Superiority or Other |
| t-test, 2 sided | 0.802 | Mean Difference (Net) | -0.10 | 95 | -0.91 | 0.70 | No | Superiority or Other |
| t-test, 2 sided | 0.191 | Mean Difference (Net) | 0.44 | 95 | -0.22 | 1.11 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.73 |
| 95 |
| -1.42 |
| -0.03 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.220 | Mean Difference (Net) | -0.44 | 95 | -1.14 | 0.26 | No | Superiority or Other |
| t-test, 2 sided | 0.278 | Mean Difference (Net) | -0.47 | 95 | -1.33 | 0.38 | No | Superiority or Other |
| t-test, 2 sided | 0.673 | Mean Difference (Net) | -0.18 | 95 | -1.04 | 0.68 | No | Superiority or Other |
| t-test, 2 sided | 0.422 | Mean Difference (Net) | 0.29 | 95 | -0.42 | 1.00 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.93 |
| 95 |
| -1.46 |
| -0.40 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.213 | Mean Difference (Net) | -0.34 | 95 | -0.87 | 0.20 | No | Superiority or Other |
| t-test, 2 sided | 0.105 | Mean Difference (Net) | -0.54 | 95 | -1.19 | 0.11 | No | Superiority or Other |
| t-test, 2 sided | 0.876 | Mean Difference (Net) | 0.05 | 95 | -0.60 | 0.70 | No | Superiority or Other |
| t-test, 2 sided | 0.033 | Mean Difference (Net) | 0.59 | 95 | 0.05 | 1.13 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.85 |
| 95 |
| -1.49 |
| -0.22 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.132 | Mean Difference (Net) | -0.49 | 95 | -1.12 | 0.15 | No | Superiority or Other |
| t-test, 2 sided | 0.024 | Mean Difference (Net) | -0.89 | 95 | -1.67 | -0.12 | No | Superiority or Other |
| t-test, 2 sided | 0.184 | Mean Difference (Net) | -0.52 | 95 | -1.30 | 0.25 | No | Superiority or Other |
| t-test, 2 sided | 0.262 | Mean Difference (Net) | 0.37 | 95 | -0.27 | 1.01 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.73 |
| 95 |
| -1.36 |
| -0.10 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.773 | Mean Difference (Net) | -0.09 | 95 | -0.73 | 0.54 | No | Superiority or Other |
| t-test, 2 sided | 0.097 | Mean Difference (Net) | -0.66 | 95 | -1.43 | 0.12 | No | Superiority or Other |
| t-test, 2 sided | 0.960 | Mean Difference (Net) | -0.02 | 95 | -0.79 | 0.75 | No | Superiority or Other |
| t-test, 2 sided | 0.052 | Mean Difference (Net) | 0.64 | 95 | 0.00 | 1.28 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.056 | 95 | No | Superiority or Other |
| Repeated Measures | 0.816 | 95 | No | Superiority or Other |
| Repeated Measures | 0.208 | 95 | No | Superiority or Other |
| Repeated Measures | 0.212 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.007 | 95 | No | Superiority or Other |
| Repeated Measures | 0.095 | 95 | No | Superiority or Other |
| Repeated Measures | 0.040 | 95 | No | Superiority or Other |
| Repeated Measures | 0.635 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.115 | 95 | No | Superiority or Other |
| Repeated Measures | 0.002 | 95 | No | Superiority or Other |
| Repeated Measures | 0.072 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.112 | 95 | No | Superiority or Other |
| Repeated Measures | 0.010 | 95 | No | Superiority or Other |
| Repeated Measures | 0.219 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.116 | 95 | No | Superiority or Other |
| Repeated Measures | 0.033 | 95 | No | Superiority or Other |
| Repeated Measures | 0.480 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.097 | 95 | No | Superiority or Other |
| Repeated Measures | 0.023 | 95 | No | Superiority or Other |
| Repeated Measures | 0.435 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.036 | 95 | No | Superiority or Other |
| Repeated Measures | 0.007 | 95 | No | Superiority or Other |
| Repeated Measures | 0.416 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.002 | 95 | No | Superiority or Other |
| Repeated Measures | 0.026 | 95 | No | Superiority or Other |
| Repeated Measures | 0.003 | 95 | No | Superiority or Other |
| Repeated Measures | 0.313 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.090 | 95 | No | Superiority or Other |
| Repeated Measures | 0.006 | 95 | No | Superiority or Other |
| Repeated Measures | 0.171 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | <0.001 | 95 | No | Superiority or Other |
| Repeated Measures | 0.128 | 95 | No | Superiority or Other |
| Repeated Measures | 0.013 | 95 | No | Superiority or Other |
| Repeated Measures | 0.225 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.035 | 95 | No | Superiority or Other |
| Repeated Measures | 0.117 | 95 | No | Superiority or Other |
| Repeated Measures | 0.060 | 95 | No | Superiority or Other |
| Repeated Measures | 0.647 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Repeated Measures | 0.236 | 95 | No | Superiority or Other |
| Repeated Measures | 0.014 | 95 | No | Superiority or Other |
| Repeated Measures | 0.036 | 95 | No | Superiority or Other |
| Repeated Measures | 0.756 | 95 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.79 |
| 95 |
| -1.30 |
| -0.29 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.233 | Mean Difference (Net) | -0.31 | 95 | -0.82 | 0.20 | No | Superiority or Other |
| t-test, 2 sided | 0.075 | Mean Difference (Net) | -0.56 | 95 | -1.19 | 0.06 | No | Superiority or Other |
| t-test, 2 sided | 0.798 | Mean Difference (Net) | -0.08 | 95 | -0.71 | 0.54 | No | Superiority or Other |
| t-test, 2 sided | 0.066 | Mean Difference (Net) | 0.48 | 95 | -0.03 | 1.00 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.033 | 95 | No | Superiority or Other |
| Fisher Exact | 0.142 | 95 | No | Superiority or Other |
| Fisher Exact | 0.049 | 95 | No | Superiority or Other |
| Fisher Exact | 0.587 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.255 | 95 | No | Superiority or Other |
| Fisher Exact | 0.107 | 95 | No | Superiority or Other |
| Fisher Exact | 0.053 | 95 | No | Superiority or Other |
| Fisher Exact | 0.779 | 95 | No | Superiority or Other |
| Mean Difference (Net) |
| -1.07 |
| 95 |
| -2.12 |
| -0.02 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.580 | Mean Difference (Net) | 0.30 | 95 | -0.76 | 1.36 | No | Superiority or Other |
| t-test, 2 sided | 0.185 | Mean Difference (Net) | -0.86 | 95 | -2.14 | 0.41 | No | Superiority or Other |
| t-test, 2 sided | 0.438 | Mean Difference (Net) | 0.51 | 95 | -0.77 | 1.79 | No | Superiority or Other |
| t-test, 2 sided | 0.012 | Mean Difference (Net) | 1.37 | 95 | 0.30 | 2.44 | No | Superiority or Other |
| Mean Difference (Net) |
| 1.02 |
| 95 |
| -1.14 |
| 3.18 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.465 | Mean Difference (Net) | -0.81 | 95 | -3.00 | 1.37 | No | Superiority or Other |
| t-test, 2 sided | 0.677 | Mean Difference (Net) | 0.56 | 95 | -2.09 | 3.21 | No | Superiority or Other |
| t-test, 2 sided | 0.345 | Mean Difference (Net) | -1.27 | 95 | -3.92 | 1.38 | No | Superiority or Other |
| t-test, 2 sided | 0.102 | Mean Difference (Net) | -1.84 | 95 | -4.04 | 0.37 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.90 |
| 95 |
| -1.44 |
| 3.24 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.150 | Mean Difference (Net) | 1.74 | 95 | -0.63 | 4.11 | No | Superiority or Other |
| t-test, 2 sided | 0.524 | Mean Difference (Net) | 0.94 | 95 | -1.96 | 3.83 | No | Superiority or Other |
| t-test, 2 sided | 0.230 | Mean Difference (Net) | 1.78 | 95 | -1.13 | 4.69 | No | Superiority or Other |
| t-test, 2 sided | 0.491 | Mean Difference (Net) | 0.84 | 95 | -1.55 | 3.23 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.60 |
| 95 |
| 0.07 |
| 1.12 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.006 | Mean Difference (Net) | 0.75 | 95 | 0.22 | 1.29 | No | Superiority or Other |
| t-test, 2 sided | 0.180 | Mean Difference (Net) | 0.44 | 95 | -0.21 | 1.10 | No | Superiority or Other |
| t-test, 2 sided | 0.069 | Mean Difference (Net) | 0.60 | 95 | -0.05 | 1.25 | No | Superiority or Other |
| t-test, 2 sided | 0.564 | Mean Difference (Net) | 0.16 | 95 | -0.38 | 0.70 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.58 |
| 95 |
| -0.21 |
| 1.36 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.700 | Mean Difference (Net) | 0.16 | 95 | -0.64 | 0.95 | No | Superiority or Other |
| t-test, 2 sided | 0.279 | Mean Difference (Net) | 0.54 | 95 | -0.44 | 1.51 | No | Superiority or Other |
| t-test, 2 sided | 0.822 | Mean Difference (Net) | 0.11 | 95 | -0.86 | 1.09 | No | Superiority or Other |
| t-test, 2 sided | 0.299 | Mean Difference (Net) | -0.42 | 95 | -1.22 | 0.38 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.60 |
| 95 |
| -0.35 |
| 1.55 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.880 | Mean Difference (Net) | 0.07 | 95 | -0.89 | 1.04 | No | Superiority or Other |
| t-test, 2 sided | 0.193 | Mean Difference (Net) | 0.78 | 95 | -0.39 | 1.94 | No | Superiority or Other |
| t-test, 2 sided | 0.675 | Mean Difference (Net) | 0.25 | 95 | -0.92 | 1.42 | No | Superiority or Other |
| t-test, 2 sided | 0.288 | Mean Difference (Net) | -0.53 | 95 | -1.50 | 0.45 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.33 |
| 95 |
| -0.69 |
| 1.35 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.089 | Mean Difference (Net) | 0.89 | 95 | -0.14 | 1.91 | No | Superiority or Other |
| t-test, 2 sided | 0.234 | Mean Difference (Net) | 0.75 | 95 | -0.49 | 2.00 | No | Superiority or Other |
| t-test, 2 sided | 0.040 | Mean Difference (Net) | 1.31 | 95 | 0.06 | 2.56 | No | Superiority or Other |
| t-test, 2 sided | 0.289 | Mean Difference (Net) | 0.56 | 95 | -0.48 | 1.59 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.11 |
| 95 |
| -0.13 |
| 0.35 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.628 | Mean Difference (Net) | 0.06 | 95 | -0.18 | 0.31 | No | Superiority or Other |
| t-test, 2 sided | 0.573 | Mean Difference (Net) | 0.09 | 95 | -0.21 | 0.38 | No | Superiority or Other |
| t-test, 2 sided | 0.819 | Mean Difference (Net) | 0.03 | 95 | -0.26 | 0.33 | No | Superiority or Other |
| t-test, 2 sided | 0.687 | Mean Difference (Net) | -0.05 | 95 | -0.30 | 0.20 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.00 |
| 95 |
| -0.40 |
| 0.40 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.793 | Mean Difference (Net) | 0.05 | 95 | -0.35 | 0.46 | No | Superiority or Other |
| t-test, 2 sided | 0.981 | Mean Difference (Net) | -0.01 | 95 | -0.50 | 0.49 | No | Superiority or Other |
| t-test, 2 sided | 0.857 | Mean Difference (Net) | 0.05 | 95 | -0.45 | 0.54 | No | Superiority or Other |
| t-test, 2 sided | 0.805 | Mean Difference (Net) | 0.05 | 95 | -0.36 | 0.46 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.04 |
| 95 |
| -0.45 |
| 0.37 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.573 | Mean Difference (Net) | -0.12 | 95 | -0.54 | 0.30 | No | Superiority or Other |
| t-test, 2 sided | 0.272 | Mean Difference (Net) | -0.29 | 95 | -0.79 | 0.22 | No | Superiority or Other |
| t-test, 2 sided | 0.161 | Mean Difference (Net) | -0.36 | 95 | -0.88 | 0.15 | No | Superiority or Other |
| t-test, 2 sided | 0.711 | Mean Difference (Net) | -0.08 | 95 | -0.50 | 0.34 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.52 |
| 95 |
| -0.44 |
| 1.49 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.351 | Mean Difference (Net) | -0.46 | 95 | -1.44 | 0.51 | No | Superiority or Other |
| t-test, 2 sided | 0.219 | Mean Difference (Net) | 0.74 | 95 | -0.44 | 1.93 | No | Superiority or Other |
| t-test, 2 sided | 0.686 | Mean Difference (Net) | -0.24 | 95 | -1.43 | 0.94 | No | Superiority or Other |
| t-test, 2 sided | 0.050 | Mean Difference (Net) | -0.98 | 95 | -1.97 | 0.00 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.02 |
| 95 |
| -0.02 |
| 0.06 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.143 | Mean Difference (Net) | 0.03 | 95 | -0.01 | 0.07 | No | Superiority or Other |
| t-test, 2 sided | 0.218 | Mean Difference (Net) | 0.03 | 95 | -0.02 | 0.08 | No | Superiority or Other |
| t-test, 2 sided | 0.100 | Mean Difference (Net) | 0.04 | 95 | -0.01 | 0.09 | No | Superiority or Other |
| t-test, 2 sided | 0.614 | Mean Difference (Net) | 0.01 | 95 | -0.03 | 0.05 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.52 |
| 95 |
| -1.85 |
| 0.81 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.043 | Mean Difference (Net) | 1.39 | 95 | 0.04 | 2.74 | No | Superiority or Other |
| t-test, 2 sided | 0.721 | Mean Difference (Net) | -0.30 | 95 | -1.92 | 1.33 | No | Superiority or Other |
| t-test, 2 sided | 0.053 | Mean Difference (Net) | 1.61 | 95 | -0.02 | 3.24 | No | Superiority or Other |
| t-test, 2 sided | 0.006 | Mean Difference (Net) | 1.91 | 95 | 0.54 | 3.27 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.13 |
| 95 |
| -0.84 |
| 0.59 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.542 | Mean Difference (Net) | -0.22 | 95 | -0.95 | 0.50 | No | Superiority or Other |
| t-test, 2 sided | 0.245 | Mean Difference (Net) | -0.52 | 95 | -1.39 | 0.36 | No | Superiority or Other |
| t-test, 2 sided | 0.169 | Mean Difference (Net) | -0.61 | 95 | -1.48 | 0.26 | No | Superiority or Other |
| t-test, 2 sided | 0.796 | Mean Difference (Net) | -0.10 | 95 | -0.82 | 0.63 | No | Superiority or Other |
| Insomnia |
|
| Nausea |
|
| Vomiting |
|
| Anxiety |
|
| Constipation |
|
| Diarrhoea |
|
| Dizziness |
|
| Dyspepsia |
|
| Erectile dysfunction |
|
| Hepatic enzyme increased |
|
| Somnolence |
|
| Abdominal pain |
|
| Abdominal pain upper |
|
| Apathy |
|
| Bursitis |
|
| Confusional state |
|
| Coordination abnormal |
|
| Decreased appetite |
|
| Disturbance in attention |
|
| Dysphoria |
|
| Ejaculation disorder |
|
| Fatigue |
|
| Gastroenteritis |
|
| Glaucoma |
|
| Headache |
|
| Hepatitis |
|
| Hot flush |
|
| Hyperhidrosis |
|
| Hypertension |
|
| Irritability |
|
| Lethargy |
|
| Loss of libido |
|
| Muscular weakness |
|
| Myocardial infarction |
|
| Palpitations |
|
| Peritonsillar abscess |
|
| Pregnancy |
|
| Rash |
|
| Restless legs syndrome |
|
| Sedation |
|
| Testicular pain |
|
| Trismus |
|
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.015 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.001 | 95 | No | Superiority or Other |
| Mean Difference (Net) |
| 2.50 |
| 95 |
| 0.11 |
| 4.89 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.191 | Mean Difference (Net) | 1.61 | 95 | -0.81 | 4.03 | No | Superiority or Other |
| t-test, 2 sided | 0.009 | Mean Difference (Net) | 3.89 | 95 | 0.97 | 6.80 | No | Superiority or Other |
| t-test, 2 sided | 0.044 | Mean Difference (Net) | 3.00 | 95 | 0.08 | 5.91 | No | Superiority or Other |
| t-test, 2 sided | 0.473 | Mean Difference (Net) | -0.89 | 95 | -3.33 | 1.55 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.14 |
| 95 |
| -3.45 |
| 3.17 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.234 | Mean Difference (Net) | 2.03 | 95 | -1.32 | 5.39 | No | Superiority or Other |
| t-test, 2 sided | 0.794 | Mean Difference (Net) | -0.54 | 95 | -4.58 | 3.50 | No | Superiority or Other |
| t-test, 2 sided | 0.426 | Mean Difference (Net) | 1.64 | 95 | -2.40 | 5.67 | No | Superiority or Other |
| t-test, 2 sided | 0.207 | Mean Difference (Net) | 2.17 | 95 | -1.21 | 5.55 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.11 |
| 95 |
| -2.35 |
| 2.14 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.002 | Mean Difference (Net) | 3.62 | 95 | 1.35 | 5.90 | No | Superiority or Other |
| t-test, 2 sided | 0.841 | Mean Difference (Net) | -0.28 | 95 | -3.02 | 2.46 | No | Superiority or Other |
| t-test, 2 sided | 0.014 | Mean Difference (Net) | 3.45 | 95 | 0.71 | 6.19 | No | Superiority or Other |
| t-test, 2 sided | 0.001 | Mean Difference (Net) | 3.73 | 95 | 1.44 | 6.02 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.46 |
| 95 |
| -1.05 |
| 0.13 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.007 | Mean Difference (Net) | -0.82 | 95 | -1.42 | -0.22 | No | Superiority or Other |
| t-test, 2 sided | 0.518 | Mean Difference (Net) | 0.24 | 95 | -0.48 | 0.96 | No | Superiority or Other |
| t-test, 2 sided | 0.734 | Mean Difference (Net) | -0.12 | 95 | -0.85 | 0.60 | No | Superiority or Other |
| t-test, 2 sided | 0.239 | Mean Difference (Net) | -0.36 | 95 | -0.97 | 0.24 | No | Superiority or Other |