Overview

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

Status:
Completed

Trial end date:
2015-05-01

Target enrollment:

Participant gender:

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

Phase:

Phase 1

Details

Lead Sponsor:

Merck KGaA
Merck KGaA, Darmstadt, Germany

Collaborator:

Swiss Tropical & Public Health Institute