NCT00233155

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 6, 2008

Status Verified

March 1, 2008

First QC Date

October 3, 2005

Last Update Submit

March 4, 2008

Conditions

Herpes ZosterNeuralgiaPainHIV InfectionsPeripheral Nervous System Diseases

Keywords

AnalgesicsCapsaicinNeuropathic painNeuropathyPHNShingles

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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.

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20538187DERIVED

MeSH Terms

Conditions

Herpes ZosterNeuralgiaPainHIV InfectionsPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jeffrey Tobias, MD

    NeurogesX

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

August 1, 2005

Study Completion

December 1, 2006

Last Updated

March 6, 2008

Record last verified: 2008-03