Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-27 @ 9:20 PM
Study NCT ID:
NCT06898268
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2025-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-22', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to treatment', 'timeFrame': '1 week', 'description': 'Reduction in vomiting episodes and preservation/increase in previous weight'}, {'measure': 'Treatment-emerged adverse events', 'timeFrame': '1 week', 'description': 'The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disorder']}, 'descriptionModule': {'briefSummary': 'This study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of Allama Iqbal Teaching Hospital, Dera Ghazi Khan.', 'detailedDescription': 'Since the FDA issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. This warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, H2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. The findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants of any gender\n* Aged 1-12 months\n* Presenting with symptoms of gastroesophageal reflux disease not responding to dietary modifications and positioning\n* Afebrile at the time of presentation\n* Vitally stable\n\nExclusion Criteria:\n\n* No evidence of hypertrophic pyloric stenosis on ultrasonography\n* Children with congenital heart disease\n* Any history of prior illness associated with symptoms\n* With abdominal distension\n* Neurological impairment, like developmentally delayed, grossly microcephalic'}, 'identificationModule': {'nctId': 'NCT06898268', 'briefTitle': 'Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux, a Comparative Study of Short Trial.', 'orgStudyIdInfo': {'id': 'DRIRUMDGKHAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metoclopramide group', 'description': 'Patients were prescribed metoclopramide twice a day for one week.', 'interventionNames': ['Drug: Metoclopramide']}, {'type': 'EXPERIMENTAL', 'label': 'Ondansetron', 'description': 'Patients in this group were put on oral ondansetron in BD doses for one week.', 'interventionNames': ['Drug: Ondansetron']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Patients were prescribed metoclopramide twice a day for one week.', 'armGroupLabels': ['Metoclopramide group']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': 'Patients were put on oral ondansetron in BD doses for one week.', 'armGroupLabels': ['Ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32200', 'city': 'Dera Ghazi Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Allama Iqbal Teaching Hospital', 'geoPoint': {'lat': 30.04587, 'lon': 70.64029}}], 'overallOfficials': [{'name': 'Irum Jabeen, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan'}, {'name': 'Asma Akbar, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If a reasonable request is made, data can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}