Status:
COMPLETED
GW679769 In Fibromyalgia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Depression
Eligibility:
All Genders
18-65 years
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 fibro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00264628
Start Date
October 1 2005
End Date
September 1 2006
Last Update
April 16 2015
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