Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
|ClinicalTrials.gov Identifier: NCT00233155|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : March 6, 2008
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases||Drug: Capsaicin Dermal Patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Phase 2 Study of NGX-4010 for the Treatment of Neuropathic Pain in Patients With Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)|
|Study Start Date :||August 2005|
|Estimated Study Completion Date :||December 2006|
- Mean percent change from baseline in "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 12 and 48, compared to baseline).
- Proportion of subjects who score 2 or 3 ("Much Improved" or "Very Much Improved") on Patient Impression of Change at Weeks 12, 24, 36 and 48.
- Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233155
|Study Director:||Jeffrey Tobias, MD||NeurogesX|