Fibromyalgia Clinical Trial
Official title:
A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
NCT number | NCT00645398 |
Other study ID # | A0081056 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2004 |
Est. completion date | June 2005 |
Verified date | April 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
Status | Completed |
Enrollment | 751 |
Est. completion date | June 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who met the American College of Rheumatology (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 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 other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia - Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders - Patients with severe depression |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Albany | New York |
United States | Pfizer Investigational Site | Altoona | Pennsylvania |
United States | Pfizer Investigational Site | Altoona | Pennsylvania |
United States | Pfizer Investigational Site | Anderson | South Carolina |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Austin | Texas |
United States | Pfizer Investigational Site | Beverly Hills | California |
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Boise | Idaho |
United States | Pfizer Investigational Site | Charleston | South Carolina |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Chicago | Illinois |
United States | Pfizer Investigational Site | Cincinnati | Ohio |
United States | Pfizer Investigational Site | Clearwater | Florida |
United States | Pfizer Investigational Site | Columbus | Ohio |
United States | Pfizer Investigational Site | Columbus | Ohio |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Danbury | Connecticut |
United States | Pfizer Investigational Site | Decatur | Georgia |
United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
United States | Pfizer Investigational Site | East Lansing | Michigan |
United States | Pfizer Investigational Site | Eugene | Oregon |
United States | Pfizer Investigational Site | Greer | South Carolina |
United States | Pfizer Investigational Site | Hot Springs | Arkansas |
United States | Pfizer Investigational Site | Huntsville | Alabama |
United States | Pfizer Investigational Site | Johnstown | Pennsylvania |
United States | Pfizer Investigational Site | Kalamazoo | Michigan |
United States | Pfizer Investigational Site | Kansas City | Missouri |
United States | Pfizer Investigational Site | Kansas City | Kansas |
United States | Pfizer Investigational Site | Lansing | Michigan |
United States | Pfizer Investigational Site | Lebanon | New Hampshire |
United States | Pfizer Investigational Site | Little Rock | Arkansas |
United States | Pfizer Investigational Site | Long Beach | California |
United States | Pfizer Investigational Site | Los Alamitos | California |
United States | Pfizer Investigational Site | Lubbock | Texas |
United States | Pfizer Investigational Site | Madisonville | Kentucky |
United States | Pfizer Investigational Site | Maywood | Illinois |
United States | Pfizer Investigational Site | Mechanicsburg | Pennsylvania |
United States | Pfizer Investigational Site | Medford | Oregon |
United States | Pfizer Investigational Site | Memphis | Tennessee |
United States | Pfizer Investigational Site | Memphis | Tennessee |
United States | Pfizer Investigational Site | Miami | Florida |
United States | Pfizer Investigational Site | Mogadore | Ohio |
United States | Pfizer Investigational Site | Nashville | Tennessee |
United States | Pfizer Investigational Site | New Milford | Connecticut |
United States | Pfizer Investigational Site | New Orleans | Louisiana |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Newport Beach | California |
United States | Pfizer Investigational Site | Newton | Massachusetts |
United States | Pfizer Investigational Site | Northridge | California |
United States | Pfizer Investigational Site | Northridge | California |
United States | Pfizer Investigational Site | Oak Brook | Illinois |
United States | Pfizer Investigational Site | Ocala | Florida |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
United States | Pfizer Investigational Site | Overland Park | Kansas |
United States | Pfizer Investigational Site | Overland Park | Kansas |
United States | Pfizer Investigational Site | Palm Beach Gardens | Florida |
United States | Pfizer Investigational Site | Paradise Valley | Arizona |
United States | Pfizer Investigational Site | Peoria | Illinois |
United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
United States | Pfizer Investigational Site | Phoenix | Arizona |
United States | Pfizer Investigational Site | Phoenix | Arizona |
United States | Pfizer Investigational Site | Pismo Beach | California |
United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
United States | Pfizer Investigational Site | Plantation | Florida |
United States | Pfizer Investigational Site | Plantation | Florida |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Pottstown | Pennsylvania |
United States | Pfizer Investigational Site | Princeton | New Jersey |
United States | Pfizer Investigational Site | Redondo Beach | California |
United States | Pfizer Investigational Site | Richardson | Texas |
United States | Pfizer Investigational Site | Riverside | California |
United States | Pfizer Investigational Site | Riverside | California |
United States | Pfizer Investigational Site | Rochester | New York |
United States | Pfizer Investigational Site | Saint Petersburg | Florida |
United States | Pfizer Investigational Site | Saint Petersburg | Florida |
United States | Pfizer Investigational Site | Saint Petersburg | Florida |
United States | Pfizer Investigational Site | Salt Lake City | Utah |
United States | Pfizer Investigational Site | San Antonio | Texas |
United States | Pfizer Investigational Site | San Antonio | Texas |
United States | Pfizer Investigational Site | Scottsdale | Arizona |
United States | Pfizer Investigational Site | Seattle | Washington |
United States | Pfizer Investigational Site | Seattle | Washington |
United States | Pfizer Investigational Site | Stratford | Connecticut |
United States | Pfizer Investigational Site | Sunrise | Florida |
United States | Pfizer Investigational Site | Toledo | Ohio |
United States | Pfizer Investigational Site | Virginia Beach | Virginia |
United States | Pfizer Investigational Site | Walnut Creek | California |
United States | Pfizer Investigational Site | West Palm Beach | Florida |
United States | Pfizer Investigational Site | West Reading | Pennsylvania |
United States | Pfizer Investigational Site | Whittier | California |
United States | Pfizer Investigational Site | Wilmington | North Carolina |
United States | Pfizer Investigational Site | Wilmington | North Carolina |
United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
United States | Pfizer Investigational Site | Woodstock | Vermont |
United States | Pfizer Investigational Site | Woodstock | Vermont |
United States | Pfizer Investigational Site | Wyomissing | Pennsylvania |
United States | Pfizer Investigational Site | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endpoint mean pain score derived from the subject's daily pain diary | Endpoint | ||
Primary | Patient Global Assessment (Patient Global Impression of Change) at Termination Visit | Weeks 5 and 13 | ||
Primary | Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit | Baseline and Weeks 5, 9, and 13 | ||
Secondary | Change from baseline in FIQ scores at Weeks 5, 9, and 13 | Baseline and Weeks 5, 9, and 13 | ||
Secondary | Change from baseline in SDS scores at Weeks 5, 9, and 13 | Baseline and Weeks 5, 9, and 13 | ||
Secondary | Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13 | Baseline and Weeks 5, 9, and 13 | ||
Secondary | Quality of Sleep Score from the Daily Sleep Diary | Daily | ||
Secondary | Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13 | Baseline and Weeks 5, 9, and 13 | ||
Secondary | Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13 | Baseline and Week 13 | ||
Secondary | Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13 | Screening, baseline, and Weeks 5, 9, and 13 | ||
Secondary | Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13 | Baseline and Weeks 9 and 13 | ||
Secondary | Adverse events | Weeks 1, 2, 5, 9, 13, and at follow-up | ||
Secondary | Physical examination, including vital signs and weight | Baseline and Week 5 (vital signs only) and 13 | ||
Secondary | Neurological examination | Screening and Week 13 | ||
Secondary | Electrocardiogram | Screening and Week 13 | ||
Secondary | Laboratory tests, including chemistry and hematology | Baseline and Weeks 5, 13, and at follow-up | ||
Secondary | Urinalysis | Baseline and Weeks 13 and at follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
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