Pain Clinical Trial
Official title:
An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
| Verified date | April 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 assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.
| Status | Terminated |
| Enrollment | 112 |
| Est. completion date | October 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial. - Patients at screening must have a score of >/=40mm on the pain visual analogue scale. Exclusion Criteria: - Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator. - Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| 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 | Clearwater | Florida |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Fort Myers | Florida |
| United States | Pfizer Investigational Site | Fullerton | California |
| United States | Pfizer Investigational Site | Gilbert | Arizona |
| United States | Pfizer Investigational Site | Holly Hill | Florida |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Houston | Texas |
| 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 | 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 | New York | New York |
| United States | Pfizer Investigational Site | Nixa | Missouri |
| 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 | Orchard Park | New York |
| United States | Pfizer Investigational Site | Ormond beach | Florida |
| United States | Pfizer Investigational Site | Palm Beach Gardens | 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 | Ruston | Louisiana |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Springfield | 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 | Topeka | Kansas |
| United States | Pfizer Investigational Site | Towson | Maryland |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| United States | Pfizer Investigational Site | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vital signs | |||
| Primary | Physical examination | |||
| Primary | 12-lead ECG | |||
| Primary | Hematology/Biochemistry | |||
| Primary | Adverse events | |||
| Secondary | Pain Visual Analogue Scale | |||
| Secondary | Patient Global Impression of Change |
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