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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 25, 2008
Last Update Posted: February 16, 2011
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.
Information provided by:
Forest Laboratories
November 24, 2008
November 25, 2008
November 18, 2010
February 16, 2011
February 16, 2011
November 2008
November 2009   (Final data collection date for primary outcome measure)
Patient Global Impression of Change (PGIC) Responder Rate at End of Study [ Time Frame: End of Randomized treatment period (11 weeks) ]
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
PGIC responder rate at end of study [ Time Frame: End of Randomized treatment period or 11 weeks ]
Complete list of historical versions of study NCT00797797 on ClinicalTrials.gov Archive Site
Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study [ Time Frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) ]
The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).
Change from baseline in VAS 1-week pain recall at end of study [ Time Frame: End of Randomized Treatment Period or 11 weeks ]
Not Provided
Not Provided
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: No Treatment Added
    No added treatment
    Other Name: Lyrica (r)
  • Drug: Milnacipran Added
    Milnacipran 100 mg/d added
  • Experimental: Milnacipran Added
    Intervention: Drug: Milnacipran Added
  • Experimental: No Treatment Added
    Intervention: Drug: No Treatment Added
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2010
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
  • tolerate at least 300 mg/day of pregabalin
  • have an incomplete response to pregabalin treatment

Exclusion Criteria:

  • suicidal risk
  • substance abuse
  • pulmonary dysfunction
  • renal impairment
  • active cardiac disease
  • liver disease
  • narrow angle glaucoma
  • autoimmune disease
  • cancer
  • inflammatory bowel disease
  • unstable endocrine disease
  • prostatic enlargement
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
Forest Laboratories
Not Provided
Study Director: Patricia D'Astoli Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Forest Laboratories
January 2011

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