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Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

NCT03261596 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-11-17

No results posted yet for this study

Summary

The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine.

Conditions

  • Hookworm Infections

Interventions

DRUG

Mebendazole

Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Noguchi Memorial Institute for Medical Research

    collaborator OTHER

  • Ghana Health Services

    collaborator OTHER_GOV

  • HopeXchange Medical Center, Ghana

    collaborator UNKNOWN

  • Kintampo Health Research Centre, Ghana

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Michael Cappello, MD · Yale University

  • Michael Wilson, PhD · University of Ghana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Ghana

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 NCT03261596 on ClinicalTrials.gov