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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-US-HMGB | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | 60-120 mg, oral, every day, 12 weeks |
|
| Placebo | Placebo Comparator | oral, daily, 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine hydrochloride | Drug | 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Impressions of Improvement (PGI-I) at Week 12 | The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse." | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint | BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 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 physician. | Phoenix | Arizona | 85050 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22753629 | Derived | Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28. | |
| 21668963 | Derived | Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359. |
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All patients were on duloxetine in the continuation phase. The continuation phase was for exploratory purpose only, and the results will not be presented further.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 60-120 mg, oral, daily, 12 weeks |
| FG001 | Placebo | oral, daily, 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Acute Double-Blind Phase |
|
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| placebo | Drug | oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment) |
|
| Baseline, 12 weeks |
| Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint | MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue. | Baseline, 12 weeks |
| Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint | BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms. | Baseline, 12 weeks |
| Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint | The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline, 12 Weeks |
| Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint | BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. | Baseline, 12 weeks |
| Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks | The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains. | Baseline, 12 weeks |
| Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint | The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42. | Baseline, 12 weeks |
| Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint | Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff. | Baseline, 12 weeks |
| Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint | Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 12 Weeks |
| Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint | Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 12 weeks |
| Change From Baseline in Blood Pressure at 12 Week Endpoint | Baseline, 12 weeks |
| Change From Baseline in Heart Rate at 12 Week Endpoint | Baseline, 12 weeks |
| Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts) | C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide. | Baseline through 12 Weeks |
| Change From Baseline in Weight at 12 Week Endpoint | Baseline, 12 weeks |
| 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 physician. | Tucson | Arizona | 85741 | 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 physician. | Los Angeles | California | 90024 | 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 physician. | Pasadena | California | 91105 | 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 physician. | Cromwell | Connecticut | 06416 | 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 physician. | Danbury | Connecticut | 06810 | 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 physician. | Bradenton | Florida | 34208 | 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 physician. | DeLand | Florida | 32720 | 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 physician. | Fort Myers | Florida | 33912 | 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 physician. | 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 physician. | 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 physician. | Tampa | Florida | 33606 | 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 physician. | West Palm Beach | Florida | 33407 | 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 physician. | Oak Brook | Illinois | 60523 | 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 physician. | Lafayette | Indiana | 47905 | 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 physician. | Prairie Village | Kansas | 66206 | 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 physician. | Rockville | Maryland | 20852 | 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 physician. | Belmont | Massachusetts | 02478 | 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 physician. | Fall River | Massachusetts | 02721 | 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 physician. | Newton | Massachusetts | 02462 | 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 physician. | Springfield | Massachusetts | 01103 | 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 physician. | Ann Arbor | Michigan | 48104 | 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 physician. | St Louis | Missouri | 63141 | 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 physician. | Edison | New Jersey | 08817 | 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 physician. | Piscataway | New Jersey | 08854 | 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 physician. | Greensboro | North Carolina | 27408 | 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 physician. | Cincinnati | Ohio | 45219 | 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 physician. | Toledo | Ohio | 43623 | 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 physician. | Oklahoma City | Oklahoma | 73109 | 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 physician. | Eugene | Oregon | 97404 | 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 physician. | Portland | Oregon | 97210 | 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 physician. | Philadelphia | Pennsylvania | 19107 | 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 physician. | Myrtle Beach | South Carolina | 29572 | 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 physician. | Dallas | Texas | 75231 | 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 physician. | Lake Jackson | Texas | 77566 | 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 physician. | San Antonio | Texas | 78229 | 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 physician. | Waco | Texas | 76708 | 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 physician. | Wichita Falls | Texas | 76309 | 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 physician. | West Jordan | Utah | 84088 | 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 physician. | Bellevue | Washington | 98007 | 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 physician. | Seattle | Washington | 98104 | 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 physician. | Tacoma | Washington | 98405 | 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 physician. | Middleton | Wisconsin | 53562 | 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 physician. | Hato Rey | 00918 | Puerto Rico |
| 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 physician. | Ponce | 00716 | Puerto Rico |
| 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 physician. | San Juan | 00935 | Puerto Rico |
| 20843911 | Derived | Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15. |
| COMPLETED |
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| NOT COMPLETED |
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| Continuation Double-Blind Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 60-120 mg, oral, daily, 12 weeks |
| BG001 | Placebo | oral, daily, 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Alcohol Consumption | Number | participants |
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| Generalized Anxiety Disorder (GAD) Status | GAD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). | Number | participants |
| |||||||||||||||
| Major Depressive Disorder (MDD) Status | MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). | Number | participants |
| |||||||||||||||
| Tobacco Use | Number | participants |
| ||||||||||||||||
| Beck Anxiety Inventory (BAI) Total Score | Beck Anxiety Inventory (BAI) is a 21-item patientcompleted questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Beck Depression Inventory II (BDI-II) Total Score | Beck Depression Inventory-II (BDI-II) is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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 |
| ||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Likert Scale Rating of Mood, Anxiety, Sleep, Pain, and Stiffness | Patient-rated likert scale assessment of: Mood - feeling low, sad or depressed (0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad, or depressed); Anxious - anxious feelings (0 = not feeling anxious to 10 = extremely anxious); Sleep - how much patient is bothered by sleep difficulties (0 = not bothered to 10 = extremely bothered); Pain - how much patient is bothered by painful physical discomforts (0 = not bothered to 10 = extremely bothered); Stiffness - how stiff patient has felt in past 24 hours (0 = has not felt any stiffness to 10 = has felt extremely stiff). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total | The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Patient's Global Impressions of Severity (PGI-S) | The PGI-Severity scale is a patient-rated instrument that measures perceived severity of symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "Normal, not at all ill," a score of 4 indicates that the patient has experienced "Moderately ill," and a score of 7 indicates that the patient is "Among the most extremely ill patients." | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| The Multidimensional Fatigue Inventory (MFI) Dimension Scores | The Multidimensional Fatigue Inventory (MFI) is a 20- item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| 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 | Patient's Global Impressions of Improvement (PGI-I) at Week 12 | The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse." | Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
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| Secondary | Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint | BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes). | Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint | MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint | BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint | The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 Weeks |
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| Secondary | Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint | BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks | The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint | The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint | Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff. | Number of patients with a non-missing baseline and at least one post-baseline record. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint | Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | Number of randomized patients with baseline and at least one post-baseline data. | Posted | Number | participants | 12 Weeks |
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| Secondary | Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint | Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | Number of randomized patients with baseline and at least one post-baseline data. | Posted | Number | participants | 12 weeks |
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| Secondary | Change From Baseline in Blood Pressure at 12 Week Endpoint | Number of patients with a baseline and at least one post-baseline result. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Heart Rate at 12 Week Endpoint | Number of patients with a baseline and at least one post-baseline result. | Posted | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 12 weeks |
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| Secondary | Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts) | C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide. | Number of randomized patients. | Posted | Number | participants | Baseline through 12 Weeks |
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| Secondary | Change From Baseline in Weight at 12 Week Endpoint | Number of patients with a baseline and at least one post-baseline result. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, 12 weeks |
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These are the adverse events which occurred during the 12 week acute double-blind 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 | 60-120 mg, oral, daily, 12 weeks | 1 | 263 | 217 | 263 | ||
| EG001 | Placebo | oral, daily, 12 weeks | 6 | 267 | 189 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA (12.0) | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
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| Lack of Efficacy |
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| Protocol Violation |
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| Sponsor Decision |
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| Physician Decision |
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| Death - Cervical vertebral fracture |
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| Male |
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| Hispanic |
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| Other - Not Specified |
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| No |
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| No |
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| No |
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| No |
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| Mood |
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| Pain |
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| Sleep |
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| Stiffness |
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| Mental Fatigue Dimension |
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| Physical Fatigue Dimension |
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| Reduced Activity Dimension |
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| Reduced Motivation Dimension |
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| No |
| Superiority or Other |
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