Clinical trial NCT00436033: A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
Official title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia Syndrome
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2007-02-16
Enrollment: 1429
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
timeFrame: 12 weeks
measure: establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).
timeFrame: 19 weeks
Other outcomes:
Locations:
city: Pardubice
country: Czech Republic
facility: Rheumatology Ambulance
city: Frederiksberg
country: Denmark
facility: FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
city: Kuopio
country: Finland
facility: Kuopion Oma Laakari Oy
city: Paris
country: France
facility: Hopital Hotel Dieu
city: Koln
country: Germany
facility: KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Lillehamer
country: Norway
facility: Center For Clinical Studies
city: Torun
country: Poland
facility: "Nasz Lekarz"
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Bucharest
country: Romania
facility: Dr I CANTACUZINO CLINICAL HOSPITAL
city: Barcelona
country: Spain
facility: Hospital de La Esperanza
city: Molndal
country: Sweden
facility: Gottfriesclinic Ab
city: London
country: United Kingdom
facility: KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
Study officials:
affiliation: HOSPITAL EGAS MONIZ
name: Dr Jaime C BRANCO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.