Safety and Efficacy Study of Pregabalin in Fibromyalgia
A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
1 other identifier
interventional
1,020
1 country
109
Brief Summary
The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2005
Shorter than P25 for phase_3
109 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
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJanuary 22, 2021
September 1, 2006
September 7, 2005
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
To evaluate the efficacy of pregabalin (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
Interventions
Eligibility Criteria
You may qualify if:
- 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 tender point sites
- At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Pfizer Investigational Site
Birmingham, Alabama, 35235, United States
Pfizer Investigational Site
Calera, Alabama, 35040, United States
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406, United States
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
Scottsdale, Arizona, 85251, United States
Pfizer Investigational Site
Fayetteville, Arkansas, 72703, United States
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
Carmichael, California, 95608, United States
Pfizer Investigational Site
Fresno, California, 93710, United States
Pfizer Investigational Site
Los Alamitos, California, 90720, United States
Pfizer Investigational Site
Northridge, California, 91324, United States
Pfizer Investigational Site
Pismo Beach, California, 93449, United States
Pfizer Investigational Site
Santa Ana, California, 92705, United States
Pfizer Investigational Site
Walnut Creek, California, 94598, United States
Pfizer Investigational Site
Whittier, California, 90601, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Stratford, Connecticut, 06615, United States
Pfizer Investigational Site
Newark, Delaware, 19713, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010, United States
Pfizer Investigational Site
Chiefland, Florida, 32680, United States
Pfizer Investigational Site
Clearwater, Florida, 33761, United States
Pfizer Investigational Site
Kissimmee, Florida, 34741, United States
Pfizer Investigational Site
Miami, Florida, 33173, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Palm Harbor, Florida, 34684, United States
Pfizer Investigational Site
Palm Springs, Florida, 33461, United States
Pfizer Investigational Site
Plantation, Florida, 33317, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33709, United States
Pfizer Investigational Site
Sunrise, Florida, 33351, United States
Pfizer Investigational Site
Tampa, Florida, 33609, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Gurnee, Illinois, 60031, United States
Pfizer Investigational Site
Peoria, Illinois, 61614, United States
Pfizer Investigational Site
Evansville, Indiana, 47712, United States
Pfizer Investigational Site
Evansville, Indiana, 47714, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46254, United States
Pfizer Investigational Site
Prairie Village, Kansas, 66206, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536-0284, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536, United States
Pfizer Investigational Site
Owensboro, Kentucky, 42303, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70114, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70128, United States
Pfizer Investigational Site
Springfield, Massachusetts, 01107, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01610, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49009, United States
Pfizer Investigational Site
Lansing, Michigan, 48917, United States
Pfizer Investigational Site
Edina, Minnesota, 55435, United States
Pfizer Investigational Site
Jackson, Mississippi, 39202, United States
Pfizer Investigational Site
Blue Springs, Missouri, 64014, United States
Pfizer Investigational Site
Springfield, Missouri, 65807, United States
Pfizer Investigational Site
Henderson, Nevada, 89014, United States
Pfizer Investigational Site
Cherry Hill, New Jersey, 08002, United States
Pfizer Investigational Site
Edison, New Jersey, 08817, United States
Pfizer Investigational Site
Highland Park, New Jersey, 08904, United States
Pfizer Investigational Site
Ridgewood, New Jersey, 07450, United States
Pfizer Investigational Site
South Eddison, New Jersey, 08817, United States
Pfizer Investigational Site
Albany, New York, 12205, United States
Pfizer Investigational Site
Johnson City, New York, 13790, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Smithtown, New York, 11787-2817, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28207, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28209, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Pfizer Investigational Site
Salisbury, North Carolina, 28144, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Columbus, Ohio, 43212, United States
Pfizer Investigational Site
Mogadore, Ohio, 44260, United States
Pfizer Investigational Site
Toledo, Ohio, 43623, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Medford, Oregon, 97504, United States
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020, United States
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218, United States
Pfizer Investigational Site
West Reading, Pennsylvania, 19611-1124, United States
Pfizer Investigational Site
Charleston, South Carolina, 29406, United States
Pfizer Investigational Site
Greenville, South Carolina, 29601, United States
Pfizer Investigational Site
Greer, South Carolina, 29651, United States
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Nashville, Tennessee, 37207, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Fort Worth, Texas, 76107, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Layton, Utah, 84041, United States
Pfizer Investigational Site
Layton, Utah, 841041, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84107, United States
Pfizer Investigational Site
South Jordan, Utah, 84095, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23454, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23455, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Seattle, Washington, 98122, United States
Pfizer Investigational Site
Seattle, Washington, 98166-2967, United States
Pfizer Investigational Site
Spokane, Washington, 99204, United States
Pfizer Investigational Site
Yakima, Washington, 98902, United States
Pfizer Investigational Site
Charleston, West Virginia, 25304, United States
Related Publications (1)
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.
PMID: 22688598DERIVED
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 7, 2005
First Posted
September 9, 2005
Study Start
April 1, 2005
Study Completion
June 1, 2006
Last Updated
January 22, 2021
Record last verified: 2006-09