GW679769 In Fibromyalgia

Completed

• Conditions: Depression; Fibromyalgia; Depressive Disorder

• Registration Number: NCT00264628
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Fibromyalgia Impact Questionnaire (FIQ) total score	throughout study

Secondary Outcome Measures

Name	Time	Method
Effect of GW679769 vs placebo in health-related quality of life outcomes	throughout study
Relationship between PK of GW679769 and clinical outcome in patients	throughout study
Safety and Tolerability	throughout study