A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
NCT ID: NCT00436033
Last Updated: 2013-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1429 participants
INTERVENTIONAL
2006-02-28
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Minalcipran
milnacipran
Interventions
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milnacipran
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Jaime C BRANCO
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL EGAS MONIZ
Locations
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Rheumatology Ambulance
Pardubice, , Czechia
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
Frederiksberg, , Denmark
Kuopion Oma Laakari Oy
Kuopio, , Finland
Hopital Hotel Dieu
Paris, , France
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Cologne, , Germany
Ospedale Luigi Sacco
Milan, , Italy
Center For Clinical Studies
Lillehamer, , Norway
"Nasz Lekarz"
Torun, , Poland
Hospital Egas Moniz
Lisbon, , Portugal
Dr I CANTACUZINO CLINICAL HOSPITAL
Bucharest, , Romania
Hospital de La Esperanza
Barcelona, , Spain
Gottfriesclinic Ab
Mölndal, , Sweden
KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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F02207GE302
Identifier Type: -
Identifier Source: org_study_id
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