NCT06720259

Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura

A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Jennifer Keiser · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.

Conditions

• Trichuris Trichiura; Infection
• Hookworm Infection
• Ascaris Lumbricoides Infection

Interventions

Type	Name	Description
DRUG	Oxantel Pamoate	Tablets containing 250 mg oxantel pamoate
DRUG	Mebendazole	Tablets containing 500 mg mebendazole

Timeline

• Start date: 2025-04-16
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2024-12-06
• Last updated: 2025-06-08

Locations

1 site across 1 country: Tanzania