GW679769 In Fibromyalgia

Depression Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264628
• Other study ID #: SND103929
• Status: Completed
• Phase: N/A
• First received: December 9, 2005
• Last updated: April 15, 2015
• Start date: October 2005
• Est. completion date: September 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• GW679769

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fibromyalgia Impact Questionnaire (FIQ) total score		throughout study
Secondary	Effect of GW679769 vs placebo in health-related quality of life outcomes		throughout study
Secondary	Relationship between PK of GW679769 and clinical outcome in patients		throughout study
Secondary	Safety and Tolerability		throughout study