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Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Minalcipran | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milnacipran | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria | 12 weeks | |
| establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). | 19 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Jaime C BRANCO | HOSPITAL EGAS MONIZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Ambulance | Pardubice | 530 02 | Czechia | |||
| FREDERIKSBERG HOSPITAL - Clinic of Rheumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20156949 | Derived | 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. |
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|
| Frederiksberg |
| F2000 |
| Denmark |
| Kuopion Oma Laakari Oy | Kuopio | 70100 | Finland |
| Hopital Hotel Dieu | Paris | France |
| KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care | Cologne | D50931 | Germany |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Center For Clinical Studies | Lillehamer | 2609 | Norway |
| "Nasz Lekarz" | Torun | Poland |
| Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Dr I CANTACUZINO CLINICAL HOSPITAL | Bucharest | 020475 | Romania |
| Hospital de La Esperanza | Barcelona | 08024 | Spain |
| Gottfriesclinic Ab | Mölndal | 43137 | Sweden |
| KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology | London | SE59RJ | United Kingdom |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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