The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabilin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.

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

Further Study Details: 

Primary Outcomes: To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale
Secondary Outcomes: To evaluate the efficacy of pregabilin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety
Expected Total Enrollment:  1020

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• At screening (V1), patients must meet the AMerican College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tendor point sites
• At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

• Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren''''s Syndrome, Sarcoid, Psoriatic ARthritis, Scleroderma)
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00151489

Pfizer CT.gov Call Center      1-800-718-1021 

Alabama
      Pfizer Investigational Site, Anniston,  Alabama,  36207,  United States; Recruiting
      Pfizer Investigational Site, Tuscaloosa,  Alabama,  35406,  United States; Recruiting
      Pfizer Investigational Site, Calera,  Alabama,  35040,  United States; Recruiting
Arizona
      Pfizer Investigational Site, Phoenix,  Arizona,  85023,  United States; Recruiting
      Pfizer Investigational Site, Scottsdale,  Arizona,  85251,  United States; Recruiting
Arkansas
      Pfizer Investigational Site, Hot Springs,  Arkansas,  71913,  United States; Recruiting
      Pfizer Investigational Site, Fayetteville,  Arkansas,  72703,  United States; Recruiting
California
      Pfizer Investigational Site, Walnut Creek,  California,  94598,  United States; Recruiting
      Pfizer Investigational Site, Anaheim,  California,  92801,  United States; Recruiting
      Pfizer Investigational Site, Santa Ana,  California,  92705,  United States; Recruiting
      Pfizer Investigational Site, Carmichael,  California,  95608,  United States; Recruiting
      Pfizer Investigational Site, Pismo Beach,  California,  93449,  United States; Recruiting
      Pfizer Investigational Site, Los Alamitos,  California,  90720,  United States; Recruiting
      Pfizer Investigational Site, Northridge,  California,  91324,  United States; Recruiting
      Pfizer Investigational Site, Fresno,  California,  93710,  United States; Recruiting
Colorado
      Pfizer Investigational Site, Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Pfizer Investigational Site, Stratford,  Connecticut,  06615,  United States; Recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Pfizer Investigational Site, Tampa,  Florida,  33609,  United States; Recruiting
      Pfizer Investigational Site, West Palm Beach,  Florida,  33409,  United States; Recruiting
      Pfizer Investigational Site, Miami,  Florida,  33173,  United States; Recruiting
      Pfizer Investigational Site, Sunrise,  Florida,  33351,  United States; Recruiting
      Pfizer Investigational Site, Clearwater,  Florida,  33761,  United States; Recruiting
      Pfizer Investigational Site, Ocala,  Florida,  34474,  United States; Recruiting
      Pfizer Investigational Site, Palm Springs,  Florida,  33461,  United States; Recruiting
      Pfizer Investigational Site, Palm Harbor,  Florida,  34684,  United States; Recruiting
      Pfizer Investigational Site, Chiefland,  Florida,  32680,  United States; No longer recruiting
      Pfizer Investigational Site, Kissimmee,  Florida,  34741,  United States; Recruiting
      Pfizer Investigational Site, Plantation,  Florida,  33317,  United States; Recruiting
      Pfizer Investigational Site, Plantation,  Florida,  33324,  United States; Recruiting
      Pfizer Investigational Site, St. Petersburg,  Florida,  33709,  United States; Recruiting
Georgia
      Pfizer Investigational Site, Atlanta,  Georgia,  30328,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Peoria,  Illinois,  61614,  United States; Recruiting
      Pfizer Investigational Site, Gurnee,  Illinois,  60031,  United States; Recruiting
Indiana
      Pfizer Investigational Site, Evansville,  Indiana,  47712,  United States; Recruiting
      Pfizer Investigational Site, Evansville,  Indiana,  47714,  United States; Recruiting
Kansas
      Pfizer Investigational Site, Prairie Village,  Kansas,  66206,  United States; Recruiting
Kentucky
      Pfizer Investigational Site, Lexington,  Kentucky,  40509,  United States; Recruiting
      Pfizer Investigational Site, Owensboro,  Kentucky,  42303,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, New Orleans,  Louisiana,  70114,  United States; Recruiting
      Pfizer Investigational Site, New Orleans,  Louisiana,  70128,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, Worcester,  Massachusetts,  01610,  United States; Recruiting
      Pfizer Investigational Site, Springfield,  Massachusetts,  01107,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Lansing,  Michigan,  48917,  United States; Recruiting
      Pfizer Investigational Site, Kalamazoo,  Michigan,  49009,  United States; Recruiting
Missouri
      Pfizer Investigational Site, Springfield,  Missouri,  65807,  United States; Recruiting
Nevada
      Pfizer Investigational Site, Henderson,  Nevada,  89014,  United States; Recruiting
New Jersey
      Pfizer Investigational Site, Cherry Hill,  New Jersey,  08002,  United States; Recruiting
      Pfizer Investigational Site, Edison,  New Jersey,  08817,  United States; Recruiting
New York
      Pfizer Investigational Site, Rochester,  New York,  14618,  United States; Recruiting
      Pfizer Investigational Site, Albany,  New York,  12205,  United States; Recruiting
      Pfizer Investigational Site, Johnson City,  New York,  13790,  United States; Recruiting
North Carolina
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Pfizer Investigational Site, Raleigh,  North Carolina,  27609,  United States; Recruiting
      Pfizer Investigational Site, Raleigh,  North Carolina,  27612,  United States; Recruiting
      Pfizer Investigational Site, Charlotte,  North Carolina,  28209,  United States; Recruiting
      Pfizer Investigational Site, Salisbury,  North Carolina,  28144,  United States; Recruiting
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Toledo,  Ohio,  43623,  United States; Recruiting
      Pfizer Investigational Site, Columbus,  Ohio,  43212,  United States; Recruiting
      Pfizer Investigational Site, Cincinnati,  Ohio,  45219,  United States; Recruiting
Oklahoma
      Pfizer Investigational Site, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Oregon
      Pfizer Investigational Site, Eugene,  Oregon,  97401,  United States; Recruiting
      Pfizer Investigational Site, Medford,  Oregon,  97504,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, West Reading,  Pennsylvania,  19611-1124,  United States; Recruiting
      Pfizer Investigational Site, Mechanicsburg,  Pennsylvania,  17055,  United States; Recruiting
      Pfizer Investigational Site, Bensalem,  Pennsylvania,  19020,  United States; Recruiting
South Carolina
      Pfizer Investigational Site, Greer,  South Carolina,  29651,  United States; Recruiting
      Pfizer Investigational Site, Charleston,  South Carolina,  29406,  United States; Recruiting
      Pfizer Investigational Site, Greenville,  South Carolina,  29601,  United States; Recruiting
South Dakota
      Pfizer Investigational Site, Sioux Falls,  South Dakota,  57105,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Memphis,  Tennessee,  38119,  United States; Recruiting
Texas
      Pfizer Investigational Site, Austin,  Texas,  78705,  United States; Recruiting
      Pfizer Investigational Site, San Antonio,  Texas,  78217,  United States; Recruiting
      Pfizer Investigational Site, Fort Worth,  Texas,  76107,  United States; Recruiting
Utah
      Pfizer Investigational Site, Salt Lake City,  Utah,  84107,  United States; Recruiting
      Pfizer Investigational Site, Layton,  Utah,  84041,  United States; Recruiting
Virginia
      Pfizer Investigational Site, Virginia Beach,  Virginia,  23454,  United States; Recruiting
      Pfizer Investigational Site, Viginia Beach,  Virginia,  23455,  United States; Recruiting
Washington
      Pfizer Investigational Site, Yakima,  Washington,  98902,  United States; Recruiting
      Pfizer Investigational Site, Spokane,  Washington,  99204,  United States; Recruiting
      Pfizer Investigational Site, Seattle,  Washington,  98166-2967,  United States; Recruiting
West Virginia
      Pfizer Investigational Site, Charleston,  West Virginia,  25304,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0081059
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151489
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13