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Praziquantel taste assessment study

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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201412000959159
Enrollment
48
Registered
2014-12-03
Start date
2015-02-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis Schistosomiasis

Interventions

L-PZQ ODT (MSC 2499550A) put on tongue
Rac-PZQ ODT (MSC1028703A) put on the tongue
L-PZQ ODT (MSC 2499550A) dispersed in water
Rac-PZQ ODT (MSC1028703A) dispersed in water
Cesol® crushed in water

Sponsors

Merck KGaA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Tanzania

Contacts

Public ContactEric Huber

Swiss TPH Project leader

eric.huber@unibas.ch+41 61 284 89 72

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026