GW679769 In Fibromyalgia

An Outpatient, Randomised, Double-blind, Placebo Controlled, Parallel Group Exploratory Study to Evaluate Safety, Tolerability and Efficacy of GW679769 in Patients With Fibromyalgia Syndrome Comorbid With Depression.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00264628

Enrollment

Registered

2005-12-13

Start date

2005-10-31

Completion date

2006-09-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Depression, Fibromyalgia

Keywords

NK1-antagonist, Depression, Fibromyalgia, GW679769, Outpatient

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.

Interventions

DRUGGW679769

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in Fibromyalgia Impact Questionnaire (FIQ) total score	throughout study

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026