GW679769 In Fibromyalgia

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

Criteria

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.