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Civamide Patch Safety, Tolerability and PK Study

NCT00758433 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2011-06-10

No results posted yet for this study

Summary

To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Zucapsaicin

Civamide patch 0.0075% q.d. 24 hours for 7 days

DRUG

Zucapsaicin

Civamide patch 0.0150% q.d. 24 hours for 7 days

DRUG

Placebo patch

Placebo patch q.d. 24 hours for 7 days

Sponsors & Collaborators

  • Winston Laboratories

    lead INDUSTRY

Principal Investigators

  • Scott B Phillips, M.D. · Winston Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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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 NCT00758433 on ClinicalTrials.gov