Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
- Conditions
- Postherpetic Neuralgia
- Interventions
- Registration Number
- NCT00809679
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
- Detailed Description
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T-62 100 mg bid T-62 Dose 1 - T-62 200 mg bid T-62 Dose 2 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in pain scores from baseline to following treatment. weekly
- Secondary Outcome Measures
Name Time Method Pharmacokinetics weekly General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories) weekly