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Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years

NCT02315352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-03-06

Study results available
· View outcomes & findings →

Summary

The primary objective of the trial is to compare the "overall palatability" of the new orally disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the current available racemate PZQ tablets (reference) as assessed by means of human gustatory sensation tests (100 millimeter \[mm\] visual analogue scale \[VAS\] scoring modified by the incorporation of a 5 point facial hedonic scale).

The secondary objectives are

* To obtain feedback from children regarding the taste of different formulations using an open ended questionnaire
* To document any discomfort or other observation in relation to acceptance of the study medication

Conditions

  • Healthy

Interventions

DRUG

L-PZQ ODT

L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water

DRUG

Rac-PZQ ODT

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water

DRUG

L-PZQ ODT

L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water

DRUG

Rac-PZQ ODT

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water

DRUG

Cesol®

Cesol® tablet at a dose of 150 mg crushed in water

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Tanzania

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 NCT02315352 on ClinicalTrials.gov