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

Phase 3

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Drug: Placebo; Drug: milnacipran

• Registration Number: NCT00436033
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1429

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Minalcipran	milnacipran	-

Primary Outcome Measures

Name	Time	Method
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	12 weeks

Secondary Outcome Measures

Name	Time	Method
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria	12 weeks
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).	19 weeks

Trial Locations

Locations (13)

Rheumatology Ambulance; 🇨🇿 Pardubice, Czech Republic

FREDERIKSBERG HOSPITAL - Clinic of Rheumatology; 🇩🇰 Frederiksberg, Denmark

Ospedale Luigi Sacco; 🇮🇹 Milano, Italy

Hopital Hotel Dieu; 🇫🇷 Paris, France

KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care; 🇩🇪 Koln, Germany

Kuopion Oma Laakari Oy; 🇫🇮 Kuopio, Finland

Center For Clinical Studies; 🇳🇴 Lillehamer, Norway

"Nasz Lekarz"; 🇵🇱 Torun, Poland

Hospital de La Esperanza; 🇪🇸 Barcelona, Spain

Gottfriesclinic Ab; 🇸🇪 Molndal, Sweden

KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology; 🇬🇧 London, United Kingdom

Hospital Egas Moniz; 🇵🇹 Lisboa, Portugal

Dr I CANTACUZINO CLINICAL HOSPITAL; 🇷🇴 Bucharest, Romania