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A Controlled Pregabalin Trial In Fibromyalgia

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 29, 2005
Last updated: October 8, 2012
Last verified: October 2012

September 29, 2005
October 8, 2012
October 2005
Not Provided
To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
Same as current
Complete list of historical versions of study NCT00230776 on Archive Site
To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.
Same as current
Not Provided
Not Provided
A Controlled Pregabalin Trial In Fibromyalgia
A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia
Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Drug: pregabalin
  • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2006
Not Provided

Inclusion Criteria:

  • Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
  • Patients must have a score of >40 mm on the Visual Analog Scale

Exclusion Criteria:

  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Not Provided
Study Director: Pfizer Call Center Pfizer
October 2012

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