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

Fibromyalgia Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436033
• Other study ID #: F02207GE302
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2007
• Last updated: July 10, 2013
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : French Health Products Safety AgencyGermany : Federal Institute for Drug and Medicinal DeviceDenmark : Danish Medicine AgencyFinland: Finnish Medicines AgencyNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyCzech Republic: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1429
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Drug:
• milnacipran

• Placebo

Locations

Country	Name	City	State
Czech Republic	Rheumatology Ambulance	Pardubice
Denmark	FREDERIKSBERG HOSPITAL - Clinic of Rheumatology	Frederiksberg
Finland	Kuopion Oma Laakari Oy	Kuopio
France	Hopital Hotel Dieu	Paris
Germany	KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care	Koln
Italy	Ospedale Luigi Sacco	Milano
Norway	Center For Clinical Studies	Lillehamer
Poland	"Nasz Lekarz"	Torun
Portugal	Hospital Egas Moniz	Lisboa
Romania	Dr I CANTACUZINO CLINICAL HOSPITAL	Bucharest
Spain	Hospital de La Esperanza	Barcelona
Sweden	Gottfriesclinic Ab	Molndal
United Kingdom	KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology	London

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Finland,  France,  Germany,  Italy,  Norway,  Poland,  Portugal,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria		12 weeks	No
Secondary	establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).		19 weeks	Yes