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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02315352
• Date of registration: 09/12/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: 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
• Scientific title: 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
• Date of first enrolment: April 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02315352
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Tanzania

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Rac-PZQ ODT

Drug: Cesol®

Drug: L-PZQ ODT

Primary Outcome(s)

Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) [Time Frame: 0 minute (Right After the Spit-out of the IMP)]

Secondary Outcome(s)

Overall Palatability VAS Score at 2-5 Minutes [Time Frame: 2-5 minutes (After the IMP has been spat out)]

Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication [Time Frame: 2-5 minutes]

Number of Subjects With Mouth Feeling and Taste Description Evaluation [Time Frame: 2-5 minutes (After the IMP has been spat out)]

Secondary ID(s)

EMR200661-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss Tropical & Public Health Institute

Results

• Results available: Yes
• Date Posted: 06/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02315352