Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-29 @ 10:34 PM
Study NCT ID:
NCT04293432
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacovigilance Study of Torsade de Pointes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6670}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of drugs associated with TdP', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019', 'description': 'The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.'}, {'measure': 'Identification of new signals of TdP', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019', 'description': 'Signal detection using disproportionality analysis'}], 'secondaryOutcomes': [{'measure': 'Validation of already known drug-TdP associations', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019'}, {'measure': 'Stratification of new signals with respect to age', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019'}, {'measure': 'Stratification of new signals with respect to gender', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019'}, {'measure': 'Trends of TdP reports in FAERS database', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019'}, {'measure': 'Description of the population of patients having TdP', 'timeFrame': 'Cases reported to the FAERS database till 31/03/2019'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Torsades de Pointe Caused by Drug']}, 'referencesModule': {'references': [{'pmid': '39291052', 'type': 'DERIVED', 'citation': 'Ali Z, Ismail M, Rehman IU, Goh KW, Razi P, Ming LC. Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System. J Pharm Policy Pract. 2024 Sep 16;17(1):2399716. doi: 10.1080/20523211.2024.2399716. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.', 'detailedDescription': 'Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presented with TdP treated for any disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TdP cases reported in the FAERS database till 31/03/2019\n* Adverse event reported was including the MedDRA term: Torsade de Pointes\n\nExclusion Criteria:\n\n* Drugs with less than 10 TdP reports'}, 'identificationModule': {'nctId': 'NCT04293432', 'briefTitle': 'A Pharmacovigilance Study of Torsade de Pointes', 'organization': {'class': 'OTHER', 'fullName': 'University of Peshawar'}, 'officialTitle': 'A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms', 'orgStudyIdInfo': {'id': 'PV-TdP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group/Cohort', 'description': 'Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)', 'interventionNames': ['Drug: Drugs, Generic']}], 'interventions': [{'name': 'Drugs, Generic', 'type': 'DRUG', 'description': 'All drugs having ≥10 TdP cases reported in the FAERS database', 'armGroupLabels': ['Group/Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Department of Pharmacy, University of Peshawar', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Peshawar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Pharmacy', 'investigatorFullName': 'Mohammad Ismail', 'investigatorAffiliation': 'University of Peshawar'}}}}