[S,S]-Reboxetine Dose-Range Finding Trial
Phase 2
Completed
- Conditions
- Pain
- Registration Number
- NCT00288652
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Tacoma, Washington, United States