NCT02315352

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

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

Detailed description

Initially pupils will be invited with their parents to school where they will be asked to give consent/assent in to the study and they will be instructed on how to follow up the taste study procedures. Enrollments will occur in the health facilities in Ikwiriri/Kibiti at the end of successive training. Informed consent from parents and guardians and assent from the child will be obtained before participation in the study. The study will be conducted in school children 6 years and older as recommended by the Committee for medical product for human use (CHMP) reflection paper: formulations of choice for the pediatric population. -This is a randomized, five-period cross over, single center swill and spit taste study where the drug will not be swallowed but will be spit out after tasting. On Day 1, the subjects will assess the palatability of the following arms in a randomized sequence: * L-PZQ ODT (150 mg) put and disintegrated in the mouth * Rac- PZQ ODT (150 mg) put and disintegrated in the mouth On Day 2, the subjects will assess the palatability of the following arms in a randomized sequence: * L-PZQ ODT (150 mg) dispersed in water administered in the mouth cavity * Rac- ODT (150 mg) dispersed in water administered in the mouth cavity * 150 mg current PZQ tablet (1/4 of a 600 mg tablet) crushed, dispersed in water and administered in the mouth cavity Gustatory sensation studies will be performed on the different formulations immediately after tasting and 2-5 min after the study drug has been spat out. All volunteers will be asked to place a mark along the line with the use of a 100 mm visual analogue scale (VAS) that incorporates a 5 points hedonic scale for "overall palatability". In addition, any discomfort or other observation in relation to acceptance of the study medication (Example: spitting out of the medicine) will be reported by the parents or investigator. An open ended questionnaire (description of mouth feeling and taste description) will be conducted for each child during the washout period. After the trial a therapeutic dose of Praziquantel will be made available to the local health council and management team to provide to the participating school.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-12-11
• Last updated: 2017-03-06
• Results posted: 2017-03-06

Locations

1 site across 1 country: Tanzania