CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 700 enrolled
Drug / intervention
Albendazole +4 moredrug
Likely dose
Albendazole 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03527745
NCT03527745Phase 2Completed

Efficacy and Safety of Ascending Dosages of Albendazole Against T. Trichiura and Hookworm in Preschool- and School-aged Children and Adults: a Randomized Controlled Trial

Jennifer Keiser·interventional·Posted May 17, 2018·Updated Jun 12, 2023

In Brief

A Phase 2 clinical trial evaluating Albendazole and Placebo for Trichuriasis and Hookworm Infections. Completed, enrolled 700 participants across 1 site.

Detailed Summary

This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years). The primary objective is to determine cure rates (primary end point, i.e. conversion from being egg positive pre-treatment to egg negative post-treatment). Secondary objectives involve the determination of egg reduction rates (the reduction in the number of excreted eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic parameters will be determined from blood samples collected with a micro-sampling device (secondary end point).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCôte d’Ivoire

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 17, 2018
Enrollment StartOct 23, 2018
Primary CompletionApr 17, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.1 years ago

Interventions

Albendazoledrug

Single dose of albendazole (200mg, dependent on treatment cohort)

Albendazoledrug

Single dose of albendazole (400mg, dependent on treatment cohort)

Albendazoledrug

Single dose of albendazole (600mg, dependent on treatment cohort)

Albendazoledrug

Single dose of albendazole (800mg, dependent on treatment cohort)

Placebodrug

Matching placebo tablets will be obtained from Fagron, Germany.