NCT00082316CompletedPhase 2
A Randomized, Open-Label Study of the Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain
NeurogesX18 sites in 1 countryStarted: May 7, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Locations
- 18
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- Not provided
Investigators
Study Sites (18)
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