Fibromyalgia Clinical Trial
Official title:
A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia
Verified date | December 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.
Status | Completed |
Enrollment | 1129 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female of any race, at least 18 years of age - Patients must meet the 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) Exclusion Criteria: - Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia - Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder - A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression - History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features |
Country | Name | City | State |
---|---|---|---|
Canada | Pfizer Investigational Site | Bathurst | New Brunswick |
Canada | Pfizer Investigational Site | Hawkesbury | Ontario |
Canada | Pfizer Investigational Site | Kelowna | British Columbia |
Canada | Pfizer Investigational Site | Moncton | New Brunswick |
Canada | Pfizer Investigational Site | Pointe Claire | Quebec |
Canada | Pfizer Investigational Site | Quebec | |
Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
Canada | Pfizer Investigational Site | Toronto | Ontario |
Canada | Pfizer Investigational Site | Toronto | Ontario |
United States | Pfizer Investigational Site | Albany | New York |
United States | Pfizer Investigational Site | Albuquerque | New Mexico |
United States | Pfizer Investigational Site | Altoona | Pennsylvania |
United States | Pfizer Investigational Site | Ann Arbor | Michigan |
United States | Pfizer Investigational Site | Arlington | Virginia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Aurora | Illinois |
United States | Pfizer Investigational Site | Austin | Texas |
United States | Pfizer Investigational Site | Austin | Texas |
United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
United States | Pfizer Investigational Site | Beaumont | Texas |
United States | Pfizer Investigational Site | Beaumont | Texas |
United States | Pfizer Investigational Site | Bend | Oregon |
United States | Pfizer Investigational Site | Bethlehem | Pennsylvania |
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Bridgeville | Pennsylvania |
United States | Pfizer Investigational Site | Bristol | Tennessee |
United States | Pfizer Investigational Site | Brockton | Massachusetts |
United States | Pfizer Investigational Site | Bronx | New York |
United States | Pfizer Investigational Site | Brooklyn | New York |
United States | Pfizer Investigational Site | Brooksville | Florida |
United States | Pfizer Investigational Site | Bryan | Texas |
United States | Pfizer Investigational Site | Carmichael | California |
United States | Pfizer Investigational Site | Chandler | Arizona |
United States | Pfizer Investigational Site | Charleston | South Carolina |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Charlottesville | Virginia |
United States | Pfizer Investigational Site | Chaska | Minnesota |
United States | Pfizer Investigational Site | Cincinnati | Ohio |
United States | Pfizer Investigational Site | Cincinnati | Ohio |
United States | Pfizer Investigational Site | Cincinnati | Ohio |
United States | Pfizer Investigational Site | Cleveland | Ohio |
United States | Pfizer Investigational Site | Columbia | Missouri |
United States | Pfizer Investigational Site | Columbia | Missouri |
United States | Pfizer Investigational Site | Columbus | Ohio |
United States | Pfizer Investigational Site | Cumberland | Rhode Island |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dayton | Ohio |
United States | Pfizer Investigational Site | DeSoto | Texas |
United States | Pfizer Investigational Site | Dubuque | Iowa |
United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
United States | Pfizer Investigational Site | Edina | Minnesota |
United States | Pfizer Investigational Site | Elk Grove | California |
United States | Pfizer Investigational Site | Eugene | Oregon |
United States | Pfizer Investigational Site | Fall River | Massachusetts |
United States | Pfizer Investigational Site | Fullerton | California |
United States | Pfizer Investigational Site | Gurnee | Illinois |
United States | Pfizer Investigational Site | Henderson | Nevada |
United States | Pfizer Investigational Site | Henderson | Nevada |
United States | Pfizer Investigational Site | Houston | Texas |
United States | Pfizer Investigational Site | Huntsville | Alabama |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Jackson | Tennessee |
United States | Pfizer Investigational Site | Jacksonville | Florida |
United States | Pfizer Investigational Site | Jacksonville | Florida |
United States | Pfizer Investigational Site | Jacksonville | Florida |
United States | Pfizer Investigational Site | Jacksonville | Florida |
United States | Pfizer Investigational Site | Jefferson City | Missouri |
United States | Pfizer Investigational Site | Johnson City | Tennessee |
United States | Pfizer Investigational Site | Kingsport | Tennessee |
United States | Pfizer Investigational Site | Kirkland | Washington |
United States | Pfizer Investigational Site | Lafayette | California |
United States | Pfizer Investigational Site | Lake Jackson | Texas |
United States | Pfizer Investigational Site | Las Vegas | Nevada |
United States | Pfizer Investigational Site | Lexington | Kentucky |
United States | Pfizer Investigational Site | Lincoln | Rhode Island |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Madisonville | Kentucky |
United States | Pfizer Investigational Site | Medford | Oregon |
United States | Pfizer Investigational Site | Milan | Tennessee |
United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
United States | Pfizer Investigational Site | Moline | Illinois |
United States | Pfizer Investigational Site | Mount Sterling | Kentucky |
United States | Pfizer Investigational Site | Nashville | Tennessee |
United States | Pfizer Investigational Site | Nassau Bay | Texas |
United States | Pfizer Investigational Site | New London | Connecticut |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | North Dartmouth | Massachusetts |
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 | Ocala | Florida |
United States | Pfizer Investigational Site | Oceanside | California |
United States | Pfizer Investigational Site | Ogden | Utah |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
United States | Pfizer Investigational Site | Olive Branch | Mississippi |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Oregon | Wisconsin |
United States | Pfizer Investigational Site | Overland Park | Kansas |
United States | Pfizer Investigational Site | Overland Park | Kansas |
United States | Pfizer Investigational Site | Phoenix | Arizona |
United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Pratt | Kansas |
United States | Pfizer Investigational Site | Rochester | New York |
United States | Pfizer Investigational Site | Rochester | New York |
United States | Pfizer Investigational Site | Rochester | Minnesota |
United States | Pfizer Investigational Site | Roseville | California |
United States | Pfizer Investigational Site | Sacramento | California |
United States | Pfizer Investigational Site | Sacramento | California |
United States | Pfizer Investigational Site | Saint Louis | Missouri |
United States | Pfizer Investigational Site | Saint Petersburg | Florida |
United States | Pfizer Investigational Site | Salisbury | North Carolina |
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 | San Jose | California |
United States | Pfizer Investigational Site | Santa Ana | California |
United States | Pfizer Investigational Site | Sarasota | Florida |
United States | Pfizer Investigational Site | Seattle | Washington |
United States | Pfizer Investigational Site | Seattle | Washington |
United States | Pfizer Investigational Site | Spokane | Washington |
United States | Pfizer Investigational Site | Sunrise | Florida |
United States | Pfizer Investigational Site | Tallassee | Alabama |
United States | Pfizer Investigational Site | Tampa | Florida |
United States | Pfizer Investigational Site | Tampa | Florida |
United States | Pfizer Investigational Site | Toledo | Ohio |
United States | Pfizer Investigational Site | Tucson | Arizona |
United States | Pfizer Investigational Site | Venice | Florida |
United States | Pfizer Investigational Site | Virginia Beach | Virginia |
United States | Pfizer Investigational Site | Warwick | Rhode Island |
United States | Pfizer Investigational Site | Watertown | Massachusetts |
United States | Pfizer Investigational Site | Wellesley Hills | Massachusetts |
United States | Pfizer Investigational Site | West Palm Beach | Florida |
United States | Pfizer Investigational Site | West Reading | Pennsylvania |
United States | Pfizer Investigational Site | Wheaton | Maryland |
United States | Pfizer Investigational Site | Willow Grove | Pennsylvania |
United States | Pfizer Investigational Site | Winter Haven | Florida |
United States | Pfizer Investigational Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the endpoint mean pain score | 14 weeks | ||
Primary | Fibromyalgia Impact Questionnaire | 14 weeks | ||
Secondary | Change from baseline in the endpoint mean sleep interference score | 14 weeks | ||
Secondary | Patient Global Impression of Change | 14 weeks | ||
Secondary | Multidimensional Assessment of Fatigue | 14 weeks | ||
Secondary | Hospital Anxiety and Depression Scale | 14 weeks | ||
Secondary | Short Form 36 | 14 weeks | ||
Secondary | Sheehan Disability Score | 14 weeks | ||
Secondary | Pain Visual Analogue Scale | 14 weeks |
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