A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
This study has been completed.
Sponsor:
Pierre Fabre Medicament
Information provided by:
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00436033
First received: February 15, 2007
Last updated: October 19, 2007
Last verified: October 2007
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Purpose
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Syndrome |
Drug: milnacipran |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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
Secondary Outcome Measures:
- comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
- establishment of safety profile of treatment of milnacipran in patients with FMS.
| Estimated Enrollment: | 824 |
| Study Start Date: | February 2006 |
| Study Completion Date: | September 2007 |
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 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 unlargement of genito urinary disorders
- for women : pregnancy or breast feeding
Contacts and Locations
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
| ClinicalTrials.gov Identifier: | NCT00436033 History of Changes |
| Other Study ID Numbers: | F02207GE302 |
| Study First Received: | February 15, 2007 |
| Last Updated: | October 19, 2007 |
| 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 May 23, 2013