Pain Clinical Trial
Official title:
[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)
| Verified date | June 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | February 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have pain present for more than 3 months after the healing of shingles skin rash - Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: - Patients with significant renal and hepatic impairment - Patients with other severe pain, that may impair the self-assessment of the pain due to shingles - Patients with clinically abnormal electrocardiogram |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Amherst | New York |
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Arcadia | California |
| United States | Pfizer Investigational Site | Asheville | North Carolina |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Billings | Montana |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| United States | Pfizer Investigational Site | Bradenton | Florida |
| United States | Pfizer Investigational Site | Brockton | Massachusetts |
| United States | Pfizer Investigational Site | Canfield | Ohio |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| 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 | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Clifton | New Jersey |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Ft. Myers | Florida |
| United States | Pfizer Investigational Site | Fullerton | California |
| United States | Pfizer Investigational Site | Hackensack | New Jersey |
| United States | Pfizer Investigational Site | Holly Hill | Florida |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Hot Springs | Arkansas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntsville | Alabama |
| United States | Pfizer Investigational Site | Independence | Missouri |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Jackson | Tennessee |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Kissimmee | Florida |
| United States | Pfizer Investigational Site | Laguna Hills | California |
| United States | Pfizer Investigational Site | Largo | Florida |
| United States | Pfizer Investigational Site | Loma Linda | California |
| United States | Pfizer Investigational Site | Longwood | Florida |
| United States | Pfizer Investigational Site | Melbourne | Florida |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Nixa | Missouri |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| 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 | Orange | California |
| United States | Pfizer Investigational Site | Orchard Park | New York |
| United States | Pfizer Investigational Site | Oviedo | Florida |
| United States | Pfizer Investigational Site | Palm Beach Gardens | Florida |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Plantation | Florida |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Redondo Beach | California |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Ruston | Louisiana |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Sante Fe | New Mexico |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Southaven | Mississippi |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Sprinfield | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Sun City | Arizona |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Teaneck | New Jersey |
| United States | Pfizer Investigational Site | Toledo | Ohio |
| United States | Pfizer Investigational Site | Topeka | Kansas |
| United States | Pfizer Investigational Site | Towson | Maryland |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Whittier | California |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated | |||
| Secondary | - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey |
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