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Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study

NCT00672035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2012-03-14

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.

The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.

Conditions

  • Traveler's Diarrhea

Interventions

BIOLOGICAL

Biological: heat-labile enterotoxin of E. coli (LT)

LT patch applied on either the deltoid or the lower back.

Sponsors & Collaborators

  • Intercell USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Noss, MD · Radiant Research, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-12-31
Completion
2008-07-31

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 NCT00672035 on ClinicalTrials.gov