NCT00809679

Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	T-62 Dose 1	Capsule dosage form 100 mg bid
DRUG	T-62 Dose 2	Capsule dosage form 200 mg bid
OTHER	Placebo	Capsule dosage form placebo bid

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-12-17
• Last updated: 2012-06-08

Locations

13 sites across 1 country: United States