Fibromyalgia Clinical Trial
Official title:
A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
| NCT number | NCT00754221 |
| Other study ID # | A6061053 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 2008 |
| Est. completion date | May 2009 |
| 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 long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
| Status | Terminated |
| Enrollment | 390 |
| 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) - Completed preceding double-blind randomized, controlled trial 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| 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 | 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 | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Medford | Oregon |
| 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 | 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 | 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 | Pittsburgh | Pennsylvania |
| 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 | Roseville | 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 Jose | California |
| United States | Pfizer Investigational Site | Santa Ana | California |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Sunrise | Florida |
| 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 | Virginia Beach | Virginia |
| 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 | 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 | Vital Signs | 66 weeks | ||
| Primary | 12-Lead ECG | 66 weeks | ||
| Primary | Hematology & Biochemistry Laboratory Parameters | 66 weeks | ||
| Primary | Adverse Events | 66 weeks | ||
| Secondary | Short-Form 36 Health Survey | 66 weeks | ||
| Secondary | Sheehan Disability Scale | 66 weeks | ||
| Secondary | Pain Visual Analogue Scale | 66 weeks | ||
| Secondary | Multidimensional Assessment of Fatigue | 66 weeks | ||
| Secondary | Fibromyalgia Impact Questionaire | 66 weeks |
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