Fibromyalgia Clinical Trial
Official title:
A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
| Verified date | December 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
| Status | Terminated |
| Enrollment | 500 |
| Est. completion date | May 18, 2009 |
| Est. primary completion date | May 18, 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of patients meeting the ACR 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) Exclusion Criteria: - Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Pellenberg | |
| 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 | Sherbrooke | Quebec |
| Czechia | Pfizer Investigational Site | Hlucin | |
| Czechia | Pfizer Investigational Site | Pardubice | |
| Czechia | Pfizer Investigational Site | Praha 2 | |
| Czechia | Pfizer Investigational Site | Zlin | |
| France | Pfizer Investigational Site | Lille | Cedex |
| France | Pfizer Investigational Site | Nice Cedex 1 | |
| France | Pfizer Investigational Site | Paris Cedex 04 | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Eichstaett | |
| Germany | Pfizer Investigational Site | Goeppingen | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Mannheim | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Korea, Republic of | Pfizer Investigational Site | Gwangju | |
| Korea, Republic of | Pfizer Investigational Site | Suwon-si | Kyeongki-do |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Emmen | |
| Netherlands | Pfizer Investigational Site | Leeuwarden | |
| South Africa | Pfizer Investigational Site | Boksburg | Gauteng |
| South Africa | Pfizer Investigational Site | Panorama | Western Cape |
| South Africa | Pfizer Investigational Site | Parow | Western Cape |
| South Africa | Pfizer Investigational Site | Pretoria | Gauteng Province |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Molndal | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| United Kingdom | Pfizer Investigational Site | Cambridge | |
| United Kingdom | Pfizer Investigational Site | Colchester | |
| United Kingdom | Pfizer Investigational Site | Derby | |
| United Kingdom | Pfizer Investigational Site | Dudley, West Midlands | |
| United Kingdom | Pfizer Investigational Site | Greenock | |
| United Kingdom | Pfizer Investigational Site | Paisley | |
| United States | Pfizer Investigational Site | Anderson | South Carolina |
| United States | Pfizer Investigational Site | Bethlehem | Pennsylvania |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cranston | Rhode Island |
| United States | Pfizer Investigational Site | Cumberland | Rhode Island |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jefferson City | Missouri |
| United States | Pfizer Investigational Site | Kenilworth | New Jersey |
| United States | Pfizer Investigational Site | Lake Jackson | Texas |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lincoln | Rhode Island |
| United States | Pfizer Investigational Site | Marion | Ohio |
| United States | Pfizer Investigational Site | Medford | Oregon |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Minot | North Dakota |
| United States | Pfizer Investigational Site | Moline | Illinois |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Orangevale | California |
| United States | Pfizer Investigational Site | Prairie Village | Kansas |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| 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 | Santa Ana | California |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Staten Island | New York |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Belgium, Canada, Czechia, France, Germany, Korea, Republic of, Netherlands, South Africa, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 12-lead ECG | 68 weeks | ||
| Primary | Hematology/Biochemistry | 68 weeks | ||
| Primary | Adverse events | 68 weeks | ||
| Primary | Physical examination | 68 weeks | ||
| Primary | Vital signs | 68 weeks | ||
| Secondary | Patient Global Impression of Change | 68 weeks |
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