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

July 10, 2013 updated by: Pierre Fabre Medicament

A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1429

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Pardubice, Czech Republic, 530 02
        • Rheumatology Ambulance
  • Denmark
      • Frederiksberg, Denmark, F2000
        • FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
  • Finland
      • Kuopio, Finland, 70100
        • Kuopion Oma Laakari Oy
  • France
      • Paris, France
        • Hôpital Hotel Dieu
  • Germany
      • Koln, Germany, D50931
        • KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
  • Italy
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
  • Norway
      • Lillehamer, Norway, 2609
        • Center for Clinical Studies
  • Poland
      • Torun, Poland
        • "Nasz Lekarz"
  • Portugal
      • Lisboa, Portugal, 1349-019
        • Hospital Egas Moniz
  • Romania
      • Bucharest, Romania, 020475
        • Dr I Cantacuzino Clinical Hospital
  • Spain
      • Barcelona, Spain, 08024
        • Hospital de la Esperanza
  • Sweden
      • Molndal, Sweden, 43137
        • Gottfriesclinic Ab
  • United Kingdom
      • London, United Kingdom, SE59RJ
        • KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Minalcipran
Drug: milnacipran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Principal Investigator: Dr Jaime C BRANCO, Hospital Egas Moniz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F02207GE302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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