Safety and Efficacy Study of Pregabalin in Fibromyalgia
NCT ID: NCT00151489
Last Updated: 2021-01-22
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
1020 participants
INTERVENTIONAL
2005-04-30
2006-06-30
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
Interventions
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pregabalin
placebo
Eligibility Criteria
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Inclusion Criteria
* At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale
Exclusion Criteria
* Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
* Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
* Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.
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
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Huntsville, Alabama, United States
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Tuscaloosa, Alabama, 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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Fayetteville, Arkansas, United States
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Hot Springs, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Fresno, California, United States
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Los Alamitos, California, United States
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Northridge, California, United States
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Pismo Beach, California, United States
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Santa Ana, California, United States
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Walnut Creek, California, United States
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Whittier, California, United States
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Denver, Colorado, United States
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Stratford, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Ocala, Florida, United States
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Palm Harbor, Florida, United States
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Palm Springs, 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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Sunrise, Florida, United States
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Tampa, 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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Gurnee, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Prairie Village, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Edina, Minnesota, United States
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Jackson, Mississippi, United States
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Blue Springs, Missouri, United States
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Springfield, Missouri, United States
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Henderson, Nevada, United States
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Cherry Hill, New Jersey, United States
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Edison, New Jersey, United States
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Highland Park, New Jersey, United States
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Ridgewood, New Jersey, United States
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South Eddison, New Jersey, United States
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Albany, New York, United States
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Johnson City, New York, United States
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Rochester, New York, United States
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Smithtown, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, 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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Mogadore, Ohio, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Bensalem, Pennsylvania, United States
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Mechanicsburg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Sioux Falls, South Dakota, 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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Fort Worth, 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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Layton, Utah, United States
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Layton, Utah, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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Virginia Beach, Virginia, 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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Seattle, Washington, United States
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Spokane, Washington, United States
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Yakima, Washington, United States
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Charleston, West Virginia, United States
Countries
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References
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Pauer L, Atkinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012 Sep;28(7):609-14. doi: 10.1097/AJP.0b013e31823dd315.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081059
Identifier Type: -
Identifier Source: org_study_id
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