Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-30 @ 1:03 PM
Study NCT ID:
NCT05076461
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cessation of vomiting', 'timeFrame': '24 hours', 'description': 'Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight while in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight. Children in both study groups were administered designated drugs in the emergency department. Children were observed in the emergency department for 6-hours and discharged if they were vomiting free. All children were asked to follow up after 24 hours for the assessment of the effectiveness of the treatment for cessation of vomiting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vomiting in Infants and/or Children', 'Acute Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.', 'detailedDescription': 'to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute gastroenteritis in children at a resource limited emergency setting of South Punjab, Pakistan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.\n\nExclusion Criteria:\n\n* Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.\n* Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.'}, 'identificationModule': {'nctId': 'NCT05076461', 'briefTitle': 'Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tehsil Headquarter Hospital'}, 'officialTitle': 'Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting', 'orgStudyIdInfo': {'id': 'TehsilHeadquarter'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ondansetron group', 'description': 'Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'Domperidone group', 'description': 'Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight', 'interventionNames': ['Drug: Ondansetron']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'description': 'Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight', 'armGroupLabels': ['Domperidone group', 'ondansetron group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64000', 'city': 'Liaquatpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Tehsil Headquarter Hospital', 'geoPoint': {'lat': 28.93618, 'lon': 70.94893}}], 'overallOfficials': [{'name': 'Tauseef Ahmad, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehsil Headquarter Hospital, Liaquatpur, Pakistan.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehsil Headquarter Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Tauseef Ahmad', 'investigatorAffiliation': 'Tehsil Headquarter Hospital'}}}}