Clinical trial NCT00233155: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Keywords: Analgesics
Capsaicin
Neuropathic pain
Neuropathy
PHN
Shingles
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
measure: Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.
Other outcomes:
Locations:
Study officials:
affiliation: NeurogesX
name: Jeffrey Tobias, MD
role: STUDY_DIRECTOR
References:
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.