A Study For Pregabalin In Patients With 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. Identifier: NCT01387607
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):

June 30, 2011
July 4, 2011
March 3, 2017
February 2012
October 2016   (Final data collection date for primary outcome measure)
Relief of pain associated with fibromyalgia by comparing with the baseline, the difference for endpoint mean pain score ( the mean of the last 7 pain diary entries) in the double-blind treatment period between pregabalin and placebo groups [ Time Frame: 14-week ]
Same as current
Complete list of historical versions of study NCT01387607 on Archive Site
  • Safety and tolerability measures include evaluating the nature, frequency and intensity of adverse events and subject discontinuations. The Suicidality assessment (STS) is also included. [ Time Frame: 14-week ]
  • Secondary efficacy endpoints include sleep, fatigue, health-related quality of life, functioning, pain, and mood disturbance will be assessed using MOS-S, Daily Sleep Diary and Subjective Sleep Questionnaire(SSQ), MAF, SF-36, VAS, HADS. [ Time Frame: 14-week ]
Same as current
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A Study For Pregabalin In Patients With Fibromyalgia
A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: pregabalin
    Pregabalin capsule, 300-450mg/day, twice daily
  • Drug: placebo
    Placebo, twice daily
  • Experimental: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Matched placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients, at least 18 years of age
  • Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
  • At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

  • Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
  • Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
  • CLcr less than 60 mL/min (estimated from serum creatinine)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Study Director: Pfizer Call Center Pfizer
March 2017

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