A Controlled Pregabalin Trial In Fibromyalgia
A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
1 other identifier
interventional
740
1 country
89
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
Shorter than P25 for phase_3
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJanuary 26, 2021
October 1, 2012
September 29, 2005
January 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Pfizer Investigational Site
Fresno, California, 93710, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
Northridge, California, 91325, United States
Pfizer Investigational Site
Pismo Beach, California, 93449, United States
Pfizer Investigational Site
Sacramento, California, 95825, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
Walnut Creek, California, 94598, United States
Pfizer Investigational Site
Newark, Delaware, 19713, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Gainesville, Florida, 32610-0221, United States
Pfizer Investigational Site
Hollywood, Florida, 33023, United States
Pfizer Investigational Site
Melbourne, Florida, 32901, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410, United States
Pfizer Investigational Site
Palm Harbor, Florida, 34684, United States
Pfizer Investigational Site
Sunrise, Florida, 33351, United States
Pfizer Investigational Site
Tampa, Florida, 33606, United States
Pfizer Investigational Site
Tampa, Florida, 33614, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Gurnee, Illinois, 60031, United States
Pfizer Investigational Site
Moline, Illinois, 61265, United States
Pfizer Investigational Site
Morton Grove, Illinois, 60053, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46202-5250, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46250, United States
Pfizer Investigational Site
Dubuque, Iowa, 52001, United States
Pfizer Investigational Site
Dubuque, Iowa, 52002, United States
Pfizer Investigational Site
Prairie Village, Kansas, 66206, United States
Pfizer Investigational Site
Pratt, Kansas, 67124, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Kenner, Louisiana, 70065, United States
Pfizer Investigational Site
Metairie, Louisiana, 70006, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747, United States
Pfizer Investigational Site
Watertown, Massachusetts, 02472, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01610, United States
Pfizer Investigational Site
Lansing, Michigan, 48910, United States
Pfizer Investigational Site
Chaska, Minnesota, 55318, United States
Pfizer Investigational Site
Saint Paul, Minnesota, 55101, United States
Pfizer Investigational Site
Jefferson City, Missouri, 65109, United States
Pfizer Investigational Site
Kansas City, Missouri, 64106, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68516, United States
Pfizer Investigational Site
Morristown, New Jersey, 07960, United States
Pfizer Investigational Site
Albany, New York, 12205, United States
Pfizer Investigational Site
Endwell, New York, 13760, United States
Pfizer Investigational Site
New York, New York, 10022-1009, United States
Pfizer Investigational Site
West Seneca, New York, 14224, United States
Pfizer Investigational Site
Asheville, North Carolina, 28801, United States
Pfizer Investigational Site
Hickory, North Carolina, 28601, United States
Pfizer Investigational Site
Hickory, North Carolina, 28602, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Salisbury, North Carolina, 28144, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Minot, North Dakota, 58701, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45227, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45245, United States
Pfizer Investigational Site
Dayton, Ohio, 45402, United States
Pfizer Investigational Site
Toledo, Ohio, 43623, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104-5428, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18103, United States
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015, United States
Pfizer Investigational Site
Norristown, Pennsylvania, 19401, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218, United States
Pfizer Investigational Site
Goose Creek, South Carolina, 29445, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572, United States
Pfizer Investigational Site
Summerville, South Carolina, 29485, United States
Pfizer Investigational Site
Chattanooga, Tennessee, 37404, United States
Pfizer Investigational Site
Knoxville, Tennessee, 37909-1900, United States
Pfizer Investigational Site
Milan, Tennessee, 38358, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Bedford, Texas, 76021, United States
Pfizer Investigational Site
Georgetown, Texas, 78626, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Killeen, Texas, 76549, United States
Pfizer Investigational Site
Lake Jackson, Texas, 77566, United States
Pfizer Investigational Site
San Antonio, Texas, 78213, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84102-1571, United States
Pfizer Investigational Site
Woodstock, Vermont, 05091, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23455, United States
Pfizer Investigational Site
Everett, Washington, 98201, United States
Pfizer Investigational Site
Spokane, Washington, 99204, United States
Pfizer Investigational Site
Spokane, Washington, 99216, United States
Pfizer Investigational Site
Tacoma, Washington, 98405, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209, United States
Related Publications (3)
Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
PMID: 26694975DERIVEDStraube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
PMID: 21639874DERIVEDBhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.
PMID: 21039311DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2005
First Posted
October 3, 2005
Study Start
October 1, 2005
Study Completion
July 1, 2006
Last Updated
January 26, 2021
Record last verified: 2012-10