GW679769 In Fibromyalgia

GlaxoSmithKline8 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Depressive Disorder Depression Fibromyalgia

Interventions

GW679769DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of fibromyalgia (ACR criteria). * Non-severe depression (HAM-D score \>14 \<24). * Women must commit to consistent use of an acceptable method of birth control. Exclusion criteria: * Severe depression (HAM-D score \> 24). * Unable to discontinue medications for pain or depression. * Laboratory and ECG value at screening outside sponsor defined ranges. * Positive to stool occult blood test.

Outcomes

Primary Outcomes

Change in Fibromyalgia Impact Questionnaire (FIQ) total score

Time frame: throughout study

Secondary Outcomes

Effect of GW679769 vs placebo in health-related quality of life outcomes

Time frame: throughout study

Relationship between PK of GW679769 and clinical outcome in patients

Time frame: throughout study

Safety and Tolerability

Time frame: throughout study

Data from ClinicalTrials.gov

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