Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00233155
First received: October 3, 2005
Last updated: March 4, 2008
Last verified: March 2008

October 3, 2005
March 4, 2008
August 2005
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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).
Mean percent change from baseline in “average pain for the past 24 hours” NPRS score (i.e., average of scores during Weeks 12, 24, 36 and 48, compared to baseline).
Complete list of historical versions of study NCT00233155 on ClinicalTrials.gov Archive Site
  • 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.
  • - 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 second through twelfth week following study patch application.
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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
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)

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 of painful HIV-AN and PHN. Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites.

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 the 12 weeks prior to study entry. One hundred eligible subjects will receive an initial open-label NGX-4010 study patch application and up to three additional open-label NGX-4010 applications at intervals of no less than 12 weeks, based on the presence or return of pain. Eligible subjects will have moderate to severe neuropathic pain secondary to HIV-AN or PHN, with average pain levels deemed appropriate for further treatment with NGX-4010 as judged by the Investigator.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Herpes Zoster
  • Neuralgia
  • Pain
  • HIV Infections
  • Peripheral Nervous System Diseases
Drug: Capsaicin Dermal Patch
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Simpson DM, Gazda S, Brown S, Webster LR, Lu SP, Tobias JK, Vanhove GF; NGX-4010 C118 Study Group. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage. 2010 Jun;39(6):1053-64. doi: 10.1016/j.jpainsymman.2009.11.316.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2006
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00233155
C118
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NeurogesX
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Study Director: Jeffrey Tobias, MD NeurogesX
NeurogesX
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP