Status:
COMPLETED
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
Lead Sponsor:
NeurogesX
Conditions:
Herpes Zoster
Neuralgia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for the treatment o...
Detailed Description
Study C118 is a multicenter, open-label, single-arm study for subjects who successfully completed a previous NGX-4010 study and have not received open-label or blinded NGX-4010 study patches within th...
Eligibility Criteria
Inclusion
- Summary eligibility criteria:
- Subjects must be in good health and have successfully completed a past trial of NGX-4010 with no past occurrence of adverse events that would contraindicate further treatment.
- The time between the last study patch on the previous study and the first study patch on this study must be at least 12 weeks.
- Topical pain medications are exclusionary and require washout prior to study patch application for this study.
- Chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application.
- Other specific inclusion and exclusion criteria must be met prior to enrollment on the study.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00233155
Start Date
August 1 2005
End Date
December 1 2006
Last Update
March 6 2008
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