Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:57 AM
Study NCT ID:
NCT07424495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory acceptability score (5-point facial hedonic scale)', 'timeFrame': 'Immediately after tablet administration (single assessment per stage)', 'description': 'Sensory acceptability will be assessed using a 5-point Facial Hedonic Scale ranging from 1 (disliked very much) to 5 (liked very much), with higher scores indicating better acceptability.'}]}, 'conditionsModule': {'keywords': ['Palatability', '3D Printing', 'Chewable Tablet', 'Pediatric Formulation', 'Sensory Acceptability', 'Pharmaceutical Technology'], 'conditions': ['Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Lajoinie A, Janiaud P, Henin E, Gleize J-C, Berlion C, Nguyen KA, Nony P, Gueyffier F, Maucort-Boulch D, Kassaï Koupaï B. Assessing the effects of solid versus liquid dosage forms of oral medications on adherence and acceptability in children. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD012783. DOI: 10.1002/14651858.CD012783.'}, {'pmid': '33236188', 'type': 'BACKGROUND', 'citation': 'Abdel-Rahman SM, Bai S, Porter-Gill PA, Goode GA, Kearns GL. A Pilot Comparison of High- Versus Low-Tech Palatability Assessment Tools in Young Children. Paediatr Drugs. 2021 Jan;23(1):95-104. doi: 10.1007/s40272-020-00430-2. Epub 2020 Nov 25.'}, {'pmid': '29997143', 'type': 'BACKGROUND', 'citation': 'Mistry P, Stirling H, Callens C, Hodson J, Batchelor H; SPaeDD-UK project. Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. BMJ Open. 2018 Jul 11;8(7):e021961. doi: 10.1136/bmjopen-2018-021961.'}, {'pmid': '23853004', 'type': 'BACKGROUND', 'citation': 'van Riet-Nales DA, de Neef BJ, Schobben AF, Ferreira JA, Egberts TC, Rademaker CM. Acceptability of different oral formulations in infants and preschool children. Arch Dis Child. 2013 Sep;98(9):725-31. doi: 10.1136/archdischild-2012-303303. Epub 2013 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The lack of appropriate pediatric formulations compromises adherence and the effectiveness of oral treatment in children, mainly due to the splitting of adult tablets and low sensory acceptability. This observational, analytical, and cross-sectional study aims to evaluate the acceptability of a novel pediatric dosage form consisting of placebo chewable tablets produced by 3D printing, with a focus on palatability and feasibility for dose personalization. Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar will be invited to participate. The study will be conducted in two stages. In the first stage, acceptability of a bear-shaped chewable tablet will be assessed, as well as preference among different flavors. In the second stage, preference for chewable tablets with or without xylitol will be investigated, in addition to dysgeusia associated with diseases or chronic medication use. Acceptability will be measured using a 5-point facial hedonic scale, evaluator observation, and age-appropriate questionnaires. The study is expected to identify the most accepted flavors and sweetness intensities, as well as to evaluate the acceptability of the 3D-printed dosage form, contributing to the development of safer, more attractive, and personalized pediatric medicines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).\n* Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).\n* Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).\n\nExclusion Criteria:\n\n* Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.\n* Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n* Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.\n* Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).\n* Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.'}, 'identificationModule': {'nctId': 'NCT07424495', 'acronym': 'ACEITA3D', 'briefTitle': 'Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Brasilia'}, 'officialTitle': 'Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents', 'orgStudyIdInfo': {'id': 'ACEITA3D'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brasilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital da Criança de Brasília José Alencar', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Marcílio Sérgio Soares da Cunha Filho', 'investigatorAffiliation': 'University of Brasilia'}}}}