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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00797797
First received: November 24, 2008
Last updated: January 20, 2011
Last verified: January 2011
History of Changes

November 24, 2008
January 20, 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
  • 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.
 
Completed
364
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797797
MLN-MD-15
No
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