Brief 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).

Trial Health

On Track

Trial Health Score

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

Enrollment

300

participants targeted

Target at P75+ for phase_2

Geographic Reach

1 country

28 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

June 3, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2003

Completed

Last Updated

March 6, 2008

Status Verified

March 1, 2008

First QC Date

June 3, 2003

Last Update Submit

March 4, 2008

Conditions

Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles

Keywords

Dermal assessmentPain measurementDiaryShinglesNeuropathyAnalgesics/*therapeutic useCapsaicin/*administration & dosage/adverse effectsHerpes Zoster/*complications/drug therapyNeuralgia/*drug therapy/etiologyPainPeripheral Nervous System Diseases/*complications

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

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.

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