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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00757731 |
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Date of registration:
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22/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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FMS European Long-Term Study
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Scientific title:
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A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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490 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00757731 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Czech Republic
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Finland
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France
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Germany
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Italy
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Norway
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Portugal
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Romania
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Spain
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Sweden
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Contacts
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Name:
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Jaime C BRANCO, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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HOSPITAL EGAS MONIZ, Lisboa, Portugal |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient who completed the 3-month F02207 GE 302 study
- patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry
of F02207 GE 302 study
Exclusion Criteria:
- known hypersensitivity to milnacipran
- 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
Age minimum:
18 Years
Age maximum:
71 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: milnacipran
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Primary Outcome(s)
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To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
[Time Frame: 12 months]
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Secondary Outcome(s)
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To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily
[Time Frame: 12 months]
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Secondary ID(s)
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F02207 GE 304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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