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A Study For Pregabalin In Patients With Fibromyalgia

This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01387607
First received: June 30, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

June 30, 2011
April 29, 2013
February 2012
October 2014   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01387607 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study For Pregabalin In Patients With Fibromyalgia
A 14-Week, Randomized, Double-Blind Placebo-Controlled Study For Pregabalin In Patients 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
324
October 2014
October 2014   (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)
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
China
 
NCT01387607
A0081241
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

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