A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
NCT ID: NCT00645398
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
751 participants
INTERVENTIONAL
2004-09-30
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
B
Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
C
Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
D
Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Interventions
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Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Eligibility Criteria
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Inclusion Criteria
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)
Exclusion Criteria
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Northridge, California, United States
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Pismo Beach, California, United States
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Redondo Beach, California, United States
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Riverside, California, United States
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Riverside, California, United States
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Walnut Creek, California, United States
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Whittier, California, United States
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Danbury, Connecticut, United States
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New Milford, Connecticut, United States
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Stratford, Connecticut, United States
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Clearwater, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Palm Beach Gardens, Florida, United States
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Plantation, Florida, United States
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Plantation, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Oak Brook, Illinois, United States
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Peoria, Illinois, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Madisonville, Kentucky, United States
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New Orleans, Louisiana, United States
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Newton, Massachusetts, United States
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East Lansing, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Kansas City, Missouri, United States
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Lebanon, New Hampshire, United States
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Princeton, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Mogadore, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Mechanicsburg, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Woodstock, Vermont, United States
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Woodstock, Vermont, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Yakima, Washington, United States
Countries
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References
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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.
Straube 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.
Bhadra 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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081056
Identifier Type: -
Identifier Source: org_study_id
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