A Study for Adult Patients With Fibromyalgia

Study Overview
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Brief Summary
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The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.

Official Title
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A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia

Conditions
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Fibromyalgia, Primary, Fibromyalgia, Secondary

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet study criteria for fibromyalgia diagnosis. Exclusion Criteria: Have previously or are currently taking duloxetine. Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder Have pain symptoms that are difficult to differentiate from fibromyalgia. Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis. Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year. Are pregnant or breast-feeding Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery Have a serious unstable medical illness Have a history of substance abuse or dependence within the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br> | Drug: Duloxetine<br>* 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks<br>* Other names: LY248686;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* QD po at the same time each day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score | BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form | BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy. | Baseline, 12 weeks | 
| Patient Global Impression - Improvement (PGI-I) at Endpoint | The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S). | 12 weeks | 
| Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint | The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S). | 12 weeks | 
| Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II) | The BDI-II is 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 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline. | Baseline, 12 weeks | 
| Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ) | FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline. | Baseline, 12 weeks | 
| Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI) | The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline. | Baseline, 12 weeks | 
| Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36) | SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model. | Baseline, 12 weeks | 
| Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation. | Baseline through 12 weeks |