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
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Neuralgia
Pain
HIV Infections
Peripheral Nervous System Diseases
Drug: Capsaicin Dermal Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NeurogesX:

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.

Estimated Enrollment: 100
Study Start Date: August 2005
Estimated Study Completion Date: December 2006
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233155

Sponsors and Collaborators
NeurogesX
Investigators
Study Director: Jeffrey Tobias, MD NeurogesX
  More Information

No publications provided by NeurogesX

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00233155     History of Changes
Other Study ID Numbers: C118
Study First Received: October 3, 2005
Last Updated: March 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NeurogesX:
Analgesics
Capsaicin
Neuropathic pain
Neuropathy
PHN
Shingles

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Zoster
Nervous System Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Pain
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014