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
490 participants
INTERVENTIONAL
2006-09-30
2008-10-31
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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Minalcipran 100 mg
milnacipran
hard capsule
Placebo
hard capsule
Minalcipran 150 mg
milnacipran
hard capsule
Placebo
hard capsule
Minalcipran 200 mg
milnacipran
hard capsule
Placebo
hard capsule
Interventions
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milnacipran
hard capsule
Placebo
hard capsule
Eligibility Criteria
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Inclusion Criteria
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study
Exclusion Criteria
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding
18 Years
71 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Jaime C BRANCO, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL EGAS MONIZ, Lisboa, Portugal
Locations
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Rheumatology Ambulance
Pardubice, , Czechia
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
Hospital Egas Moniz
Lisbon, , Portugal
Dr I CANTACUZINO CLINICAL HOSPITAL
Bucharest, , Romania
Hospital de La Esperanza
Barcelona, , Spain
Gottfriesclinic Ab
Mölndal, , Sweden
Countries
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References
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Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.
Other Identifiers
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F02207 GE 304
Identifier Type: -
Identifier Source: org_study_id
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