Back to resultsStudy of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
Primary Purpose
Herpes Zoster, Neuralgia, Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Capsaicin Dermal Patch
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Zoster focused on measuring Analgesics, Capsaicin, Neuropathic pain, Neuropathy, PHN, Shingles
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233155
Brief Title
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NeurogesX
4. Oversight
5. Study Description
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 of painful HIV-AN and PHN. Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases
Keywords
Analgesics, Capsaicin, Neuropathic pain, Neuropathy, PHN, Shingles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capsaicin Dermal Patch
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Tobias, MD
Organizational Affiliation
NeurogesX
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20538187
Citation
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.
Results Reference
derived
Learn more about this trial
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
We'll reach out to this number within 24 hrs