EUCTR2017-000278-13-FR
Active, not recruiting
Phase 1
Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulation (apricot-flavored oral powder in sachet to be diluted).
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Young healthy volunteers (7-12 years)
- Sponsor
- BIOPROJET PHARMA
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Children, boys and girls, aged from 7 to 12 years in good health
- •\-Capable of performing the taste assessment, according to the investigator’s judgment
- •\-Willing to participate to the taste assessment and to give his (her) assent in writing after a process of appropriate information according to his (her) capacity of understanding
- •\-The informed consent of the parent or legal representative should be obtained for the participation of his(her) child
- •\-Parent or legal representative, in good health, capable of performing the taste assessment and having signed the specific informed consent for his(her) own participation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •For the 2 populations, adult and children
- •\-Previous history of sensitivity or allergy to the active substance or any medicinal products or excipients
- •\-Subjects with rare hereditary problems of fructose intolerance, glucose\-galactose malabsorption syndrome or saccharase\-isomaltase deficiency
- •\-Presence of any condition that could influence taste sensations within the 5 days before the test (upper respiratory infection, fever, buccal mucositis, aphtous ulcers)
- •\-Intake within the 4 hours preceeding the test of substances that could interfere with taste sensation (highly spiced meals, mint or menthol – based products, chewing\-gums)
- •Specific for children
- •\-Child incapable, according the investigator’s opinion, to perform the test as planned in the protocol (to keep the product in the mouth without swallowing and then spit it out) and/or to express his (her) own taste impression
- •\-Child has not given his (her) assent to participate or informed consent was not obtained from the parent
Outcomes
Primary Outcomes
Not specified
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