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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00797797
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Sponsor:
Information provided by:
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Results First Submitted Date  ICMJE November 18, 2010
Results First Posted Date  ICMJE February 16, 2011
Last Update Posted Date February 16, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
PGIC responder rate at end of study [ Time Frame: End of Randomized treatment period or 11 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Change from baseline in VAS 1-week pain recall at end of study [ Time Frame: End of Randomized Treatment Period or 11 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
Official Title  ICMJE 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
Brief Summary To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: No Treatment Added
    No added treatment
    Other Name: Lyrica (r)
  • Drug: Milnacipran Added
    Milnacipran 100 mg/d added
Study Arms  ICMJE
  • Experimental: Milnacipran Added
    Intervention: Drug: Milnacipran Added
  • Experimental: No Treatment Added
    Intervention: Drug: No Treatment Added
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
364
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
320
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT00797797
Other Study ID Numbers  ICMJE MLN-MD-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patricia D'Astoli Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
PRS Account Forest Laboratories
Verification Date January 2011

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