A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

• 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