At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Single Blind, Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets of PZQ and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
In Brief
A Phase 1 clinical trial evaluating L-PZQ ODT, Rac-PZQ ODT, and 1 other intervention for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water
Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water
L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water
Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water
Cesol® tablet at a dose of 150 mg crushed in water