Status:
COMPLETED
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
Lead Sponsor:
Forest Laboratories
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
Eligibility Criteria
Inclusion
- diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
- tolerate at least 300 mg/day of pregabalin
- have an incomplete response to pregabalin treatment
Exclusion
- suicidal risk
- substance abuse
- pulmonary dysfunction
- renal impairment
- active cardiac disease
- liver disease
- narrow angle glaucoma
- autoimmune disease
- cancer
- inflammatory bowel disease
- unstable endocrine disease
- prostatic enlargement
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00797797
Start Date
November 1 2008
End Date
January 1 2010
Last Update
February 16 2011
Active Locations (60)
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1
Forest Investigative Site
Birmingham, Alabama, United States, 35205
2
Forest Investigative Site
Mesa, Arizona, United States, 85210
3
Forest Investigative Site
Peoria, Arizona, United States, 85381
4
Forest Investigative Site
Hot Springs, Arkansas, United States, 71913