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
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 740
Study Start Date: October 2005
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230776

  Hide Study Locations
Locations
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93710
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Northridge, California, United States, 91325
Pfizer Investigational Site
Pismo Beach, California, United States, 93449
Pfizer Investigational Site
Sacramento, California, United States, 95825
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Gainesville, Florida, United States, 32610-0221
Pfizer Investigational Site
Hollywood, Florida, United States, 33023
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Pfizer Investigational Site
Palm Harbor, Florida, United States, 34684
Pfizer Investigational Site
Sunrise, Florida, United States, 33351
Pfizer Investigational Site
Tampa, Florida, United States, 33606
Pfizer Investigational Site
Tampa, Florida, United States, 33614
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
Pfizer Investigational Site
Moline, Illinois, United States, 61265
Pfizer Investigational Site
Morton Grove, Illinois, United States, 60053
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202-5250
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Iowa
Pfizer Investigational Site
Dubuque, Iowa, United States, 52001
Pfizer Investigational Site
Dubuque, Iowa, United States, 52002
United States, Kansas
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206
Pfizer Investigational Site
Pratt, Kansas, United States, 67124
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Louisiana
Pfizer Investigational Site
Kenner, Louisiana, United States, 70065
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Pfizer Investigational Site
N. Dartmouth, Massachusetts, United States, 02747
Pfizer Investigational Site
Watertown, Massachusetts, United States, 02472
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site
Lansing, Michigan, United States, 48910
United States, Minnesota
Pfizer Investigational Site
Chaska, Minnesota, United States, 55318
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55101
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65109
Pfizer Investigational Site
Kansas City, Missouri, United States, 64106
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Pfizer Investigational Site
Morristown, New Jersey, United States, 07960
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12205
Pfizer Investigational Site
Endwell, New York, United States, 13760
Pfizer Investigational Site
New York, New York, United States, 10022-1009
Pfizer Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Pfizer Investigational Site
Asheville, North Carolina, United States, 28801
Pfizer Investigational Site
Hickory, North Carolina, United States, 28601
Pfizer Investigational Site
Hickory, North Carolina, United States, 28602
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
Pfizer Investigational Site
Salisbury, North Carolina, United States, 28144
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Pfizer Investigational Site
Minot, North Dakota, United States, 58701
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45245
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Dayton, Ohio, United States, 45402
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104-5428
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18103
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Norristown, Pennsylvania, United States, 19401
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15218
United States, South Carolina
Pfizer Investigational Site
Goose Creek, South Carolina, United States, 29445
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Pfizer Investigational Site
Mt Pleasant, South Carolina, United States, 29464
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Pfizer Investigational Site
Summerville, South Carolina, United States, 29485
United States, Tennessee
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37909-1900
Pfizer Investigational Site
Milan, Tennessee, United States, 38358
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Bedford, Texas, United States, 76021
Pfizer Investigational Site
Georgetown, Texas, United States, 78626
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Killeen, Texas, United States, 76549
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78213
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102-1571
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23455
United States, Washington
Pfizer Investigational Site
Everett, Washington, United States, 98201
Pfizer Investigational Site
Spokane, Washington, United States, 99216
Pfizer Investigational Site
Spokane, Washington, United States, 99204
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00230776     History of Changes
Other Study ID Numbers: A0081077
Study First Received: September 29, 2005
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 25, 2014