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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Swiss Tropical & Public Health Institute

Criteria

Inclusion criteria:

1. Children male or female aged 6-11 years (inclusive)

2. Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent

3. Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial

4. Subjects should be able to hold 2 milliliter (mL) of any appropriate juice in their mouth for 10 seconds without swallowing it and to keep a candy in the mouth for 20 seconds without swallowing it

5. Children who are able to properly assess and differentiate flavours of different soft drinks

6. Children who are able to use a hedonic scale (children were trained before the study)

Exclusion criteria:

1. Unlikely to comply with the protocol requirements, instructions and trial-related restrictions, example: uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial

2. Children with any condition or dietary habit known to interfere with the sense of smell and taste, ingestion of any medication (except paracetamol)

3. Children with significant illness in the previous 2 weeks

4. Any surgical or medical condition, or any significant disease that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the subject in the study that could interfere with the study objectives, conduct or evaluation

5. Children who have participated in any clinical investigation within the previous 4 weeks