Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 5:40 PM
Study NCT ID:
NCT06175806
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2023-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.', 'timeFrame': 'at 6 hours and at 48 hours of adminsteration', 'description': 'The number of vomiting episodes.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nausea and Vomiting in Pediatric Age Group']}, 'descriptionModule': {'briefSummary': "The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.\n\nExclusion Criteria:\n\n* Patients who are severely dehydrated.\n* Patients who have bloody vomiting.\n* Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy.\n* Patients who have vomiting due to surgical causes like intestinal obstruction.'}, 'identificationModule': {'nctId': 'NCT06175806', 'briefTitle': 'Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'FMASU MS 519/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arm I (group A) who will receive dispersible film ondansetron', 'description': 'arm I (group A) who will receive dispersible film ondansetron in a dose of 4 mg for those who will weigh more than 15 Kg up to 30 kg, and 8 mg for those who will weigh more than 30 Kg. The dose will be repeated if the patient had another vomiting episode within 15 minutes of taking the medicine.', 'interventionNames': ['Drug: Ondansetron Oral Film']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (group B) who will receive oral Granisetron', 'description': 'Arm II (group B) who will receive oral Granisetron in a dose of 40 microgram/kg/dose; the dose could be repeated if needed after 12 hours.', 'interventionNames': ['Drug: Granisetron Oral Liquid Product']}], 'interventions': [{'name': 'Ondansetron Oral Film', 'type': 'DRUG', 'description': '5-hydroxytryptamine (5-HT) receptor antagonist', 'armGroupLabels': ['arm I (group A) who will receive dispersible film ondansetron']}, {'name': 'Granisetron Oral Liquid Product', 'type': 'DRUG', 'description': '5-hydroxytryptamine (5-HT) receptor antagonist', 'armGroupLabels': ['Arm II (group B) who will receive oral Granisetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1181', 'city': 'Cairo', 'state': 'Abbasia', 'country': 'Egypt', 'facility': 'Faculty of Medicine-Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed F Allam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Family Medicine, Faculty of Medicine, Ain shams University'}, {'name': 'May F Nassar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of pediatrics, Faculty of Medicine, Ain shams University'}, {'name': 'Ehab K Emam, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of pediatrics, Faculty of Medicine, Ain shams University'}, {'name': 'Haya E Ibrahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer of pediatrics,Faculty of Medicine, Ain shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pediatrics', 'investigatorFullName': 'Haya Essam Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}