A Phase 2 interventional study of capsaicin 8% and Lidocaine (2.5%)/Prilocaine (2.5%) Cream in Postherpetic Neuralgia, sponsored by NeurogesX. Completed at 6 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-09-09.
Sponsored by NeurogesX · Phase 2, Interventional, and Treatment
This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.
Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →NeurogesX is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: capsaicin 8%
Pre-treatment for NGX-4010
Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream
High concentration capsaicin 8% dermal patch applied for one hour
Pre-treatment for NGX-4010
Duration of patch application
Time frame: Day of treatment
Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment
Time frame: Day of treatment
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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NeurogesX