Young healthy volunteers (7-12 years) MedDRA version: 19.1 Level: LLT Classification code 10055955 Term: Acute diarrhoea System Organ Class: 100000004856
Conditions
Interventions
Product Name: Racecadotril
Pharmaceutical Form: Oral suspension
Trade Name: Tiorfan®30 mg granules for oral suspension
Product Name: Racecadotril
Pharmaceutical Form: Granules for oral suspension
Sponsors
BIOPROJET PHARMA
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the non-inferiority of the palatability of a new paediatric formulation of Racecadotril strawberry-flavored administered as oral suspension via a graduated oral syringe compared to the current formulation (apricot-flavored oral powder pack) in healthy children 7-12 years of age.;Secondary Objective: Predictibility of palatability preference of the child by his (her) parent.;Primary end point(s): The primary endpoint is the score of a 7-point hedonic facial scale: scored from 1 (super bad) to 7 (super good), assessed by children just after swishing and spitting out the drug.;Timepoint(s) of evaluation of this end point: After swishing and spitting out each formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -the score on the numeric scale for the 4 taste perceptions (sweet, salt, sour and bitter) -the evaluations by the parent : - the score of Verbal 9-point hedonic scale - the score on the visual scale for the 4 taste perceptions (sweet, salt, sour and bitter) on the verbal sensory 9-point scale - the answers on the questionnaire on acceptability: taste, texture, aftertaste and ease of administration;Timepoint(s) of evaluation of this end point: After swishing and spitting out each formulation + 2 minutes later for parents. | — |
Countries
France
Contacts
Public ContactBioprojet clinical departement
BIOPROJET PHARMA
Outcome results
None listed