Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Phase 3

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00190866
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

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Exclusion Criteria

• Have any current primary Axis I diagnosis other than major depressive disorder
• Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
• Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
• Have regional pain syndrome, multiple surgeries or failed back syndrome
• Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Secondary Outcome Measures

Name	Time	Method
Sheehan Disability Scale total score
Average pain item of the BPI and the endpoint of the PGI-Improvement
Reduction of pain severity
Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
Quality of life
Effect duloxetine on pain is independent of MDD or mood improvement
Assess safety of duloxetine

Trial Locations

Locations (3)

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician; 🇺🇸 Portland, Oregon, 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, 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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇵🇷 San Juan, Puerto Rico