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

Phase 3CompletedNCT00436033

Pierre Fabre Medicament1,429 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,429

Conditions

Fibromyalgia Syndrome

Interventions

milnacipranDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (13)

Rheumatology Ambulance

Pardubice, Czechia

FREDERIKSBERG HOSPITAL - Clinic of Rheumatology

Frederiksberg, Denmark

Kuopion Oma Laakari Oy

Kuopio, Finland

Outcomes

Primary Outcomes

To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion

Time frame: 12 weeks

Secondary Outcomes

comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria

Time frame: 12 weeks

establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).

Time frame: 19 weeks

Data from ClinicalTrials.gov

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