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A Safety Study of Mebendazole in Children 2 to 10 Years of Age

NCT01173562 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2014-03-12

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Mebendazole

Type= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Tanzania

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 NCT01173562 on ClinicalTrials.gov