GW679769 In Fibromyalgia

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Fibromyalgia; Depression; Depressive Disorder

Treatments: Drug: GW679769

Study type: Observational

Funder types: Industry

Identifiers

NCT00264628

SND103929

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.