Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases, Shingles
Conditions
Keywords
Dermal assessment, Pain measurement, Diary, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral Nervous System Diseases/*complications
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).
Detailed description
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin). Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.
Interventions
Sponsors
NeurogesX
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Countries
United States
Outcome results
None listed