NCT00916942

Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)

An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NeurogesX · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed. Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	capsaicin 8%	High concentration capsaicin 8% dermal patch applied for one hour
DRUG	Lidocaine (2.5%)/Prilocaine (2.5%) Cream	Pre-treatment for NGX-4010

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2009-06-10
• Last updated: 2009-09-09

Locations

6 sites across 1 country: United States