Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
Phase 2
Completed
- Conditions
- Pain
- Registration Number
- NCT00143442
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the effectiveness of \[S,S\]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
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 > or = 40 mm on the pain visual analogue scale.
Exclusion Criteria
- Patients with poor renal function.
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
- Patients with abnormal electrocardiogram.
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 5 will be calculated.
- Secondary Outcome Measures
Name Time Method - The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire