Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMEN |
Not provided
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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.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase |
|
| Placebo | Placebo Comparator | every day (QD), by mouth (PO), 13 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores | 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). | Baseline, Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Impression of Improvement (PGI-I) | A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse). | Week 13 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events During the Dose-Blind Extension Phase | Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. | Week 13 though Week 54 |
| Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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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 p | Curitiba | 80060240 | Brazil |
| 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. | |
| 20546509 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase |
| FG001 | Placebo | every day (QD), by mouth (PO), 13 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute Double-Blind Period |
|
| |||||||||||||||||||||
| Dose-Blind Extension Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase |
| BG001 | Placebo |
| 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 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Number of participants with baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 13 |
|
Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine | 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
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Not provided
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Not provided
Not provided
|
| Placebo | Drug | every day (QD), by mouth (PO), 13 weeks |
|
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). |
| Baseline, Week 13, Week 54 |
| Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items. | Baseline, Week 13 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. | Baseline, Week 13, Week 54 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline, Week 13, Week 54 |
| Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria | Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. | Week 13 |
| Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria | Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. | Week 13 |
| Change From Baseline to Week 13 and Week 54 Endpoints 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, Week 54 |
| Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36) | 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). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. | Baseline, Week 13 |
| Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | 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. Scores presented used the UK Based Index Score. | Baseline, Week 13 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.
| Baseline, Week 13, Week 54 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores | 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, Week 54 |
| Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores | 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 |
| Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate | Baseline, Week 13 |
| Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid | Baseline, Week 13 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate | Baseline, Week 13, Week 54 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure | Baseline, Week 13, Week 54 |
| Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight | Baseline, Week 13, Week 54 |
Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. |
| Week 13 through Week 54 |
| 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 p | São Paulo | 04026-000 | Brazil |
| 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 p | São Paulo | 04027-000 | Brazil |
| 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 p | Amiens | 80054 | France |
| 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 p | Marseille | 13008 | France |
| 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 p | Paris | 75014 | France |
| 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 p | Saint-Affrique | 12400 | France |
| 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 p | Saint-Etienne | 42055 | France |
| 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 p | Ellwangen | 73479 | Germany |
| 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 p | Gräfelfing | 82166 | Germany |
| 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 p | Hamburg | 22143 | Germany |
| 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 p | Wiesbaden | 65191 | Germany |
| 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 p | Mexico City | 06700 | Mexico |
| 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 p | Monterrey | 64460 | Mexico |
| 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 p | San Pedro Garza García | 66260 | Mexico |
| 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 p | Amsterdam | 1105 AZ | Netherlands |
| 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 p | Rotterdam | 3039 BD | Netherlands |
| Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13. |
| 20461028 | Derived | Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6. |
| Protocol Violation |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| NOT COMPLETED |
|
|
every day (QD), by mouth (PO), 13 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Brief Pain Inventory (BPI) 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 |
|
| Duration of Chronic Lower Back Pain Since Onset | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Placebo |
every day (QD), by mouth (PO), 13 weeks |
|
|
|
| Secondary | Patient's Global Impression of Improvement (PGI-I) | A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse). | Number of participants with at least one non-missing post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score | Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale | 24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items. | Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria | Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. | Number of randomized participants with non-missing response values. | Posted | Number | participants | Week 13 |
|
|
|
|
| Secondary | Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria | Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented. | Number of randomized participants with non-missing response values. | Posted | Number | participants | Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints 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 participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36) | 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). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | 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. Scores presented used the UK Based Index Score. | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.
| Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores | 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 participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores | 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 participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 13 |
|
|
|
|
| Secondary | Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate | Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward. | Posted | Mean | Standard Deviation | millimole per Liter (mmol/L) | Baseline, Week 13 |
|
|
|
|
| Secondary | Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid | Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward. | Posted | Mean | Standard Deviation | micromole per Liter (μmol/L) | Baseline, Week 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | mm Hg | Baseline, Week 13, Week 54 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight | Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, Week 13, Week 54 |
|
|
|
|
| Other Pre-specified | Serious Adverse Events During the Dose-Blind Extension Phase | Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. | Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group. | Posted | Number | participants | Week 13 though Week 54 |
|
|
|
| Other Pre-specified | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase | Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0. | Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group. | Posted | Number | participant | Week 13 through Week 54 |
|
|
|
| 5 |
| 115 |
| 72 |
| 115 |
| EG001 | Placebo | every day (QD), by mouth (PO), 13 weeks | 1 | 121 | 59 | 121 |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |
| 54 Week Baseline (n=59, n=82) |
|
| 54 Week Change from Baseline (n=59, n=82) |
|
| Worst Pain Score Baseline |
|
| Worst Pain Score Change from Baseline |
|
| Night Pain Score Baseline |
|
| Night Pain Score Change from Baseline |
|
P-value for Worst Pain Score Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.007 | P-value for Night Pain Score Change from Baseline. | 95 | No | Superiority or Other |
| Worst Pain Score Week 54 Baseline (n=80, n=97) |
|
| Worst Pain Score Week 54 Change from Baseline |
|
| Least Pain Score Week 13 Baseline |
|
| Least Pain Score Week 13 Change from Baseline |
|
| Least Pain Score Week 54 Baseline (n=80, n=97) |
|
| Least Pain Score Week 54 Change from Baseline |
|
| Average Pain Score Week 13 Baseline |
|
| Average Pain Score Week 13 Change from Baseline |
|
| Average Pain Score Week 54 Baseline (n=80, n=97) |
|
| Average Pain Score Week 54 Change from Baseline |
|
| Pain Right Now Score Week 13 Baseline |
|
| Pain Right Now Score Week 13 Change from Baseline |
|
| Pain Right Now Score Week 54 Baseline (n=80, n=97) |
|
| Pain Right Now Score Week 54 Change from Baseline |
|
| General Activity Week 13 Baseline |
|
| General Activity Week 13 Change from Baseline |
|
| General Activity Week 54 Baseline (n=80, n=97) |
|
| General Activity Week 54 Change from Baseline |
|
| Mood Week 13 Baseline |
|
| Mood Week 13 Change from Baseline |
|
| Mood Week 54 Baseline (n=80, n=97) |
|
| Mood Week 54 Change from Baseline |
|
| Walking Ability Week 13 Baseline |
|
| Walking Ability Week 13 Change from Baseline |
|
| Walking Ability Week 54 Baseline (n=80, n=97) |
|
| Walking Ability Week 54 Change from Baseline |
|
| Normal Work Week 13 Baseline |
|
| Normal Work Week 13 Change from Baseline |
|
| Normal Work Week 54 Baseline (n=80, n=97) |
|
| Normal Work Week 54 Change from Baseline |
|
| Relations With People Week 13 Baseline |
|
| Relations With People Week 13 Change from Baseline |
|
| Relations With People Week 54 Baseline (n=80,n=97) |
|
| Relations With People Week 54 Change from Baseline |
|
| Sleep Week 13 Baseline |
|
| Sleep Week 13 Change from Baseline |
|
| Sleep Week 54 Baseline (n=80, n=97) |
|
| Sleep Week 54 Change from Baseline |
|
| Enjoyment of Life Week 13 Baseline |
|
| Enjoyment of Life Week 13 Change from Baseline |
|
| Enjoyment of Life Week 54 Baseline (n=80, n=97) |
|
| Enjoyment of Life Week 54 Change from Baseline |
|
| Average Interference Week 13 Baseline |
|
| Average Interference Week 13 Change from Baseline |
|
| Average Interference Week 54 Baseline (n=80, n=97) |
|
| Average Interference Week 54 Change from Baseline |
|
P-value for Least Pain Score Week 13 Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.019 | P-value for Average Pain Score Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.002 | P-value for Pain Right Now Score Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.068 | P-value for General Activity Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.009 | P-value for Mood Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.006 | P-value for Walking Ability Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.024 | P-value for Normal Work Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.005 | P-value for Relations With People Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.051 | P-value for Sleep Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.013 | P-value for Enjoyment of Life Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.005 | P-value for Average Interference Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| Week 54 Baseline (n=81, n=97) |
|
| Week 54 Change from Baseline (n=81, n=97) |
|
| Week 54 Baseline (n=71, n=86) |
|
| Week 54 Change from Baseline (n=71, n=86) |
|
| Physical Component Summary Baseline |
|
| Physical Component Summary Change from Baseline |
|
| Bodily Pain Baseline |
|
| Bodily Pain Change from Baseline |
|
| General Health Baseline |
|
| General Health Change from Baseline |
|
| Mental Health Baseline |
|
| Mental Health Change from Baseline |
|
| Physical Functioning Baseline |
|
| Physical Functioning Change from Baseline |
|
| Role-Emotional Baseline |
|
| Role-Emotional Change from Baseline |
|
| Role-Physical Baseline |
|
| Role-Physical Change from Baseline |
|
| Social Functioning Baseline |
|
| Social Functioning Change from Baseline |
|
| Vitality Baseline |
|
| Vitality Change from Baseline |
|
P-value for Physical Component Summary Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.038 | P-value for Bodily Pain Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.041 | P-value for General Health Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.093 | P-value for Mental Health Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.210 | P-value for Physical Functioning Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.170 | P-value for Role-Emotional Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.306 | P-value for Role-Physical Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.053 | P-value for Social Functioning Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.040 | P-value for Vitality Change from Baseline. | 95 | No | Superiority or Other |
| Absenteeism Score Week 54 Baseline (n=24, n=32) |
|
| Absenteeism Score Week 54 Change from Baseline |
|
| Presenteeism Score Week 13 Baseline (n=37, n=31) |
|
| Presenteeism Score Week 13 Change from Baseline |
|
| Presenteeism Score Week 54 Baseline (n=24, n=34) |
|
| Presenteeism Score Week 54 Change from Baseline |
|
| Work Productivity Loss Week 13 Baseline(n=33,n=29) |
|
| Work Productivity Loss Week 13 Change |
|
| Work Productivity Loss Week 54 Baseline(n=24,n=32) |
|
| Work Productivity Loss Week 54 Change |
|
| Activity Impairment Week 13 Baseline (n=103,n=105) |
|
| Activity Impairment Week 13 Change from Baseline |
|
| Activity Impairment Week 54 Baseline (n=70, n=86) |
|
| Activity Impairment Week 54 Change from Baseline |
|
P-value for Presenteeism Week 13 Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.736 | P-value for Work Productivity Loss Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| ANCOVA | 0.002 | P-value for Work Activity Impairment Week 13 Change from Baseline. | 95 | No | Superiority or Other |
| Week 54 Baseline (n=80, n=97) |
|
| Week 54 Change from Baseline (n=80, n=97) |
|
| Depression Subscale Baseline (n=103, n=105) |
|
| Depression Subscale Change from Baseline |
|
P-value for Depression Subscale Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| Week 54 Baseline (n=76, n=90) |
|
| Week 54 Change from Baseline |
|
| SBP Week 54 Baseline (n=76, n=90) |
|
| SBP Week 54 Change from Baseline |
|
| Diastolic Blood Pressure (DBP) Week 13 Baseline |
|
| DBP Week 13 Change from Baseline |
|
| DBP Week 54 Baseline (n=76, n=90) |
|
| DBP Week 54 Change from Baseline |
|
P-value for DBP Week 13 Change from Baseline. |
| 95 |
| No |
| Superiority or Other |
| Week 54 Baseline (n=81, n=97) |
|
| Week 54 Change from Baseline |
|
| Title | Measurements |
|---|---|
|
| Angiopathy |
|
| Back pain |
|
| Femur fracture |
|
| Hand fracture |
|
| Osteoarthritis |
|
| Road traffic accident |
|
| Suicidal ideation |
|
| Syncope |
|
| Tonsillitis |
|
| Title | Measurements |
|---|---|
|
| Hyperhidrosis |
|