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Completed

NCT Number: NCT00436033

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rheumatology Ambulance, Pardubice, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milnacipran

Drug

Placebo

Drug

Primary outcomes

  1. 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

    Time frame: 12 weeks

Secondary outcomes

  1. comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria

    Time frame: 12 weeks

  2. establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).

    Time frame: 19 weeks

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 16, 2007
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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