Status:
COMPLETED
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
Eligibility Criteria
Inclusion
- patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria
Exclusion
- psychiatric illness
- depression of generalised anxiety disorder
- suicidal risk
- substance abuse
- active cardiac disease
- pulmonary dysfunction
- liver disease
- renal impairment
- autoimmune disease
- chronic inflammatory rheumatoid disease
- current systemic infection
- epileptic
- active cancer
- sleep apnea
- active peptic ulcer
- inflammatory bowel disease
- unstable endocrine disease
- for men : prostatic enlargement of genito-urinary disorders
- for women : pregnancy or breast feeding
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
1429 Patients enrolled
Trial Details
Trial ID
NCT00436033
Start Date
February 1 2006
End Date
September 1 2007
Last Update
July 11 2013
Active Locations (13)
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1
Rheumatology Ambulance
Pardubice, Czechia, 530 02
2
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
Frederiksberg, Denmark, F2000
3
Kuopion Oma Laakari Oy
Kuopio, Finland, 70100
4
Hopital Hotel Dieu
Paris, France