Status:
COMPLETED
FMS European Long-Term Study
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18-71 years
Phase:
PHASE3
Brief Summary
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.
Eligibility Criteria
Inclusion
- patient who completed the 3-month F02207 GE 302 study
- patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study
Exclusion
- known hypersensitivity to milnacipran
- major depressive episode
- significant risk of suicide
- generalised anxiety disorder
- substance abuse
- clinically significant cardiac disease
- pulmonary dysfunction
- active liver disease
- renal impairment
- autoimmune disease
- current systemic infection
- epileptic
- active cancer
- severe sleep apnoea
- active peptic ulcer
- inflammatory bowel disease
- unstable endocrine disease
- (for men) prostatic enlargement or other genito-urinary disorders
- (for women) pregnancy or breastfeeding
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00757731
Start Date
September 1 2006
End Date
October 1 2008
Last Update
July 11 2013
Active Locations (10)
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1
Rheumatology Ambulance
Pardubice, Czechia, 530 02
2
Kuopion Oma Laakari Oy
Kuopio, Finland, 70100
3
Hopital Hotel Dieu
Paris, France
4
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Cologne, Germany, D50931