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Assessment of Drug Efficacy of Local Albendazole

NCT02420574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 679

Last updated 2022-12-09

No results posted yet for this study

Summary

Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson \& Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)

Conditions

  • Helminthiasis

Interventions

DRUG

albendazole BENDEX

randomized clinical trial with 2 parallel arms

DRUG

albendazole OVIS

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Jozef Vercruysse, PhD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-04-30
Completion
2015-02-28

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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 NCT02420574 on ClinicalTrials.gov