A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers

NCT00912262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-06-03

No results posted yet for this study

Summary

The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.

Conditions

Interventions

DRUG

Capsaicin Topical Liquid

Sponsors & Collaborators

  • NeurogesX

    lead INDUSTRY

Principal Investigators

  • Jeff Tobias, MD · NeurogesX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912262 on ClinicalTrials.gov