Diabetes Mellitus, Diabetic Neuropathies, Herpes Zoster, HIV Infections, Neuralgia, Pain, Peripheral Nervous System Diseases, Polyneuropathies
Conditions
Keywords
Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies, Complementary Therapies
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).
Interventions
Sponsors
NeurogesX
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Countries
United States
Outcome results
None listed