Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Phase 2
Terminated
- Conditions
- Pain
- Registration Number
- NCT00159640
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 315
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 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 To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.
- Secondary Outcome Measures
Name Time Method - Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)
Trial Locations
- Locations (1)
Pfizer Investigational Site