Brief Summary

This study is a randomized, open-label multi-center evaluation of the tolerability of treatment with NGX-4010 in conjunction with pre-patch topical application of one of three 4% lidocaine-based local anesthetic products. Eligible subjects will have moderate to severe neuropathic pain secondary to painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN) or HIV-associated neuropathy (HIV-AN), with average numeric pain rating scale (NPRS) scores during screening of 3 to 8 (inclusive).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach

1 country

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2004

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2004

Completed

Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

May 5, 2004

Last Update Submit

January 3, 2008

Conditions

Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Polyneuropathies

Keywords

Dermal assessmentPain assessmentDiaryAnalgesicsCapsaicinHerpes zosterNeuralgiaHIV InfectionsPeripheral Nervous System DiseasesDiabetic NeuropathiesDiabetes MellitusPolyneuropathiesComplementary Therapies

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Key Eligibility Criteria: * Must have had for at least 3 months painful diabetic neuropathy, or postherpetic neuralgia, or painful HIV-associated neuropathy, with moderate to severe pain on average. * Must not have significant pain due to other causes (for example, arthritis). * Must have intact 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 (12 weeks). * Must not use topical pain medications on painful areas. * Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation. * Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed. * No significant medical problems of the heart, kidneys, liver or lungs, or cancer. * No history or current problem with substance abuse.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.