MedPath

Praziquantel taste assessment study

Not Applicable
Conditions
Schistosomiasis
Registration Number
PACTR201412000959159
Lead Sponsor
Merck KGaA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall palatability will be assessed by putting a mark along the 0-100 millimeter VAS that incorporates a 5-point hedonic scale
Secondary Outcome Measures
NameTimeMethod
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.
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