A Controlled Pregabalin Trial In Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00230776
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 ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Fibromyalgia
  • Drug: pregabalin
  • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
740
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230776
A0081077
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

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