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

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

Timeline

Start

2015-04

Primary completion

2015-05

Completion

2015-05

Publications

• Background CHMP. (2005). Reflection paper: formulation of choice for the paediatric population. EMA
• Mahende MK, Huber E, Kourany-Lefoll E, Ali A, Hayward B, Bezuidenhout D, Bagchus W, Kabanywanyi AM. Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study. PLoS Negl Trop Dis. 2021 Jun 9;15(6):e0007370. doi: 10.1371/journal.pntd.0007370. eCollection 2021 Jun.

Drugs

Indications

No indication recorded.