NGX-4010 for the Treatment of Postherpetic Neuralgia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeurogesX
• Treatments: Capsaicin

Criteria

Key Eligibility Criteria:

• Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.

• Must not have significant pain due to causes other than PHN (for example, arthritis).

• Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.

• Must have intact and unbroken skin at the treatment area.

• Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (1-year).

• Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.

• Must not use topical pain medications for PHN.

• Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.

• No significant medical problems of the heart, kidneys, liver or lungs, or cancer.

• No history or current problem with substance abuse.