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L-PZQ ODT in Schistosoma Infected Children

NCT03845140 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2024-03-21

Study results available
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Summary

The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.

Conditions

  • Schistosomiasis

Interventions

DRUG

L-PZQ ODT 50 mg/kg

Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.

DRUG

Biltricide®

Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.

DRUG

L-PZQ ODT 60 mg/kg

Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2021-10-11
Completion
2021-10-11

Countries

  • Côte d’Ivoire
  • Kenya

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 NCT03845140 on ClinicalTrials.gov