Trial | NCT00436033  Report issue

Title

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    milnacipran ...

  • Study Participants

    1429
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
Study Started
Feb 28
2006
Primary Completion
Sep 30
2007
Study Completion
Sep 30
2007
Last Update
Jul 11
2013
Estimate

Drug milnacipran

Drug Placebo

Placebo Placebo Comparator

Minalcipran Experimental

Criteria 

Inclusion Criteria:

patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (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 enlargement of genito-urinary disorders
for women : pregnancy or breast feeding
No Results Posted