Clinical Trials Nct-pagina

Summary
EudraCT Number:2017-000278-13
Sponsor's Protocol Code Number:P16-07/BP052
National Competent Authority:France - ANSM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2017-05-03
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedFrance - ANSM
A.2EudraCT number2017-000278-13
A.3Full title of the trial
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).
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
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).
A.4.1Sponsor's protocol code numberP16-07/BP052
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorBIOPROJET PHARMA
B.1.3.4CountryFrance
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportBIOPROJET PHARMA
B.4.2CountryFrance
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationBIOPROJET PHARMA
B.5.2Functional name of contact pointBioprojet clinical departement
B.5.3 Address:
B.5.3.1Street Address9 rue Rameau
B.5.3.2Town/ cityParis
B.5.3.3Post code75002
B.5.3.4CountryFrance
B.5.4Telephone number0033(0)1 47 03 66 33
B.5.5Fax number0033(0)1 47 03 66 30
B.5.6E-mailcontact@bioprojet.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRacecadotril
D.3.4Pharmaceutical form Oral suspension
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Tiorfan®30 mg granules for oral suspension
D.2.1.1.2Name of the Marketing Authorisation holderBioprojet Pharma
D.2.1.2Country which granted the Marketing AuthorisationFrance
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRacecadotril
D.3.4Pharmaceutical form Granules for oral suspension
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Young healthy volunteers (7-12 years)
E.1.1.1Medical condition in easily understood language
Young healthy volunteers (7-12 years)
E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 19.1
E.1.2Level LLT
E.1.2Classification code 10055955
E.1.2Term Acute diarrhoea
E.1.2System Organ Class 100000004856
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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.
E.2.2Secondary objectives of the trial
Predictibility of palatability preference of the child by his (her) parent.
E.2.3Trial contains a sub-study No
E.3Principal 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
E.4Principal 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
E.5 End points
E.5.1Primary 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.
E.5.1.1Timepoint(s) of evaluation of this end point
After swishing and spitting out each formulation.
E.5.2Secondary 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
E.5.2.1Timepoint(s) of evaluation of this end point
After swishing and spitting out each formulation + 2 minutes later for parents.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Palatability/acceptability test
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Yes
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other Yes
E.7.1.3.1Other trial type description
palatability/acceptability test
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
two formulation of the same medicinal product are tested.
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
E.8.4.1Number of sites anticipated in Member State concerned1
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
last visit of the last subject
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months3
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months3
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 40
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 40
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers Yes
F.3.2Patients No
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state40
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 40
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
done
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2017-04-11
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted

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