Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases
Intervention: Capsaicin Dermal Patch (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: NeurogesX Official(s) and/or principal investigator(s):
Jeffrey Tobias, MD, Study Director, Affiliation: NeurogesX
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 of painful HIV-AN and PHN. Participation is limited to former study subjects
from previous trials of NGX-4010 at selected sites.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: 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.
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 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: August 2005
Last updated: March 4, 2008
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