Status:
COMPLETED
Study of Milnacipran for the Treatment of Fibromyalgia
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Cypress Bioscience, Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.
Eligibility Criteria
Inclusion
- diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
Exclusion
- psychiatric illness,
- depression,
- suicidal risk,
- substance abuse,
- pulmonary dysfunction,
- renal impairment,
- active cardiac disease,
- liver disease,
- autoimmune disease,
- cancer,
- inflammatory bowel disease
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1025 Patients enrolled
Trial Details
Trial ID
NCT00314249
Start Date
April 1 2006
Last Update
January 20 2010
Active Locations (24)
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1
Forest Investigative Site
Tuscaloosa, Alabama, United States, 35406
2
Forest Investigative Site
Fresno, California, United States, 93710
3
Forest Investigative Site
Pismo Beach, California, United States, 93449
4
Forest Investigative Site
Vista, California, United States, 92083