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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00436033
First received: February 15, 2007
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Fibromyalgia Syndrome
Drug: milnacipran
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1429
Study Start Date: February 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Minalcipran Drug: milnacipran

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436033

Locations
Czech Republic
Rheumatology Ambulance
Pardubice, Czech Republic, 530 02
Denmark
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
Frederiksberg, Denmark, F2000
Finland
Kuopion Oma Laakari Oy
Kuopio, Finland, 70100
France
Hopital Hotel Dieu
Paris, France
Germany
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Koln, Germany, D50931
Italy
Ospedale Luigi Sacco
Milano, Italy, 20157
Norway
Center For Clinical Studies
Lillehamer, Norway, 2609
Poland
"Nasz Lekarz"
Torun, Poland
Portugal
Hospital Egas Moniz
Lisboa, Portugal, 1349-019
Romania
Dr I CANTACUZINO CLINICAL HOSPITAL
Bucharest, Romania, 020475
Spain
Hospital de La Esperanza
Barcelona, Spain, 08024
Sweden
Gottfriesclinic Ab
Molndal, Sweden, 43137
United Kingdom
KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
London, United Kingdom, SE59RJ
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Principal Investigator: Dr Jaime C BRANCO HOSPITAL EGAS MONIZ
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT00436033     History of Changes
Other Study ID Numbers: F02207GE302
Study First Received: February 15, 2007
Last Updated: July 10, 2013
Health Authority: France : French Health Products Safety Agency
Germany : Federal Institute for Drug and Medicinal Device
Denmark : Danish Medicine Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 28, 2014