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Study 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
NeurogesX
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring Analgesics, Capsaicin, Neuropathic pain, Neuropathy, PHN, Shingles

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 3, 2005
    Last Updated
    March 4, 2008
    Sponsor
    NeurogesX
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    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)

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