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Study of Milnacipran for the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00098124
Recruitment Status : Completed
First Posted : December 6, 2004
Last Update Posted : December 24, 2007
Sponsor:
Information provided by:
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE December 3, 2004
First Posted Date  ICMJE December 6, 2004
Last Update Posted Date December 24, 2007
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
Composite responder analysis based on pain and patient global status, with or without physical function.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Composite responder analysis based on pain, patient global status, and physical function.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Quality of Life
  • Health Assessment Questionnaire (HAQ) Disability Index
  • Fatigue, sleep and cognitive assessments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Milnacipran for the Treatment of Fibromyalgia
Official Title  ICMJE A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Brief Summary Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: milnacipran hydrochloride
Study Arms  ICMJE Not Provided
Publications * Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009. Erratum in: Clin Ther. 2009 Feb;31(2):446. Clin Ther. 2009 Jul;31(7):1617.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 24, 2006)
1200
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
783
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

  • Psychiatric illness
  • Depression
  • Suicidal risk
  • Substance abuse
  • Pulmonary dysfunction
  • Renal impairment
  • Active cardiac disease
  • Liver disease
  • Autoimmune disease
  • Cancer
  • Sleep apnea
  • Inflammatory bowel disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098124
Other Study ID Numbers  ICMJE MLN-MD-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Forest Laboratories
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP