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

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia Syndrome

Treatments: Drug: milnacipran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436033

F02207GE302

Details and patient eligibility

About

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

Enrollment: 1,429 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,429 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Minalcipran

Experimental group

Treatment:

Drug: milnacipran