Praziquantel taste assessment study

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201412000959159
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: Praziquantel taste assessment study
• 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: 02/02/2015
• Target sample size: 48
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=959
• Study type: Interventional
• Study design: Crossover: all participants receive all interventions in different sequence during study,Randomised,stratified allocation by gender and agegroup,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: Eric Huber
• Affiliation: Swiss TPH Project leader

• Name: Wilhelmina Bagchus
• Affiliation: EMD Serono R&D Institute Protocol Lead

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 will be 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 Year(s)
Age maximum: 11 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Schistosomiasis
Schistosomiasis

Schistosomiasis

Intervention(s)

Cesol® crushed in water

L-PZQ ODT (MSC 2499550A) put on tongue

Rac-PZQ ODT (MSC1028703A) dispersed in water

Rac-PZQ ODT (MSC1028703A) put on the tongue

L-PZQ ODT (MSC 2499550A) dispersed in water

Primary Outcome(s)

Overall palatability will be assessed by putting a mark along the 0-100 millimeter VAS that incorporates a 5-point hedonic scale

Secondary Outcome(s)

Overall palatability will be assessed by putting a mark along the 0-100 millimeter VAS that incorporates a 5-point hedonic scale and answering the questionnaire that contains "very poor taste", "poor taste", "neither good nor bad", "good taste" and "very good taste" where higher score indicates good taste.

Secondary ID(s)

EMR200661-002

NCT Number Pending

Source(s) of Monetary Support

Merck KGaA

Ethics review

Status: Approved
Approval date: 11/10/2014
Contact:

Ifakara Health Institute-IRB

Status: Not approved
Approval date:
Contact:

Ethics Committee Northwestern/Central Switzerland

Status: Not approved
Approval date:
Contact:

National Institute for Medical Research (NIMR)