Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-31 @ 6:59 AM
Study NCT ID:
NCT02278432
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2014-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-18', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment magnesium serum level', 'timeFrame': 'at least one day', 'description': 'Level magnesium serum will be considered normal when ranged among 1.9 to 2.5 mg/dL.'}, {'measure': 'Assessment of creatinine serum level', 'timeFrame': 'at least one day', 'description': 'Creatinine serum level will be considered normal when ranged among 0,5 a1,2 mg/dL.'}, {'measure': 'Assessment of urea serum level', 'timeFrame': 'at least one day', 'description': 'Urea serum level will be considered normal when ranged among 15 a 45 mg/dL'}], 'secondaryOutcomes': [{'measure': 'Assessment of omeprazole effectiveness and adverse drug reaction', 'timeFrame': 'at least one day', 'description': 'Effectiveness and safety of omeprazole are going to be performed by patient report and analysis of medical records.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['risk assessment', 'pharmacovigilance', 'pharmacoepidemiology', 'drug toxicity', 'adverse drug reaction reporting system', 'omeprazole'], 'conditions': ['Omeprazole']}, 'referencesModule': {'references': [{'pmid': '24626940', 'type': 'BACKGROUND', 'citation': 'Varallo FR, Capucho HC, Silva Planeta Cd, Carvalho Mastroianni Pd. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital. Clinics (Sao Paulo). 2014 Mar;69(3):163-7. doi: 10.6061/clinics/2014(03)03.'}, {'pmid': '19203303', 'type': 'BACKGROUND', 'citation': 'Talley NJ. Risks of proton-pump inhibitors: what every doctor should know. Med J Aust. 2009 Feb 2;190(3):109-10. doi: 10.5694/j.1326-5377.2009.tb02305.x. No abstract available.'}, {'pmid': '23680271', 'type': 'BACKGROUND', 'citation': 'Faulhaber GA, Ascoli BM, Lubini A, Mossmann M, Rossi G, Geib G, Furlanetto TW. Serum magnesium and proton-pump inhibitors use: a cross-sectional study. Rev Assoc Med Bras (1992). 2013 May-Jun;59(3):276-9. doi: 10.1016/j.ramb.2012.12.007. Epub 2013 May 13.'}, {'pmid': '17916308', 'type': 'BACKGROUND', 'citation': 'Ameijeiras AH, Gonzalez BC, Zuniga VL. [A survey of gastroprotective drugs: prescription-indication in hospitalized patients]. Gac Sanit. 2007 Sep-Oct;21(5):412-5. doi: 10.1157/13110449. Spanish.'}, {'pmid': '29759903', 'type': 'DERIVED', 'citation': 'Varallo FR, de Nadai TR, de Oliveira ARA, Mastroianni PC. Potential Adverse Drug Events and Nephrotoxicity Related to Prophylaxis With Omeprazole for Digestive Disorders: A Prospective Cohort Study. Clin Ther. 2018 Jun;40(6):973-982. doi: 10.1016/j.clinthera.2018.04.013.'}]}, 'descriptionModule': {'briefSummary': 'Introduction. The prevalence of the use of drugs that act on the gastric system has increased in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal protection against damage caused by nonsteroidal anti-inflammatory drugs and during Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events due to abusive use or irrational prescribing, in disagreement with the indication, which may cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess the risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use of omeprazole in hospitalized patients and to know the reasons for the prophylactic use (indicated use or not approved). Patients and Methods. A observational and cross pharmacoepidemiological study will be performed from June to November 2014, in the General State tertiary referral Américo Brasiliense Hospital. Hospitalized patients will be separated into three groups: those who make indicated and approved prophylactic use of omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use (exposed group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not make prophylactic use of omeprazole will be excluded. Patients will have their pharmacotherapy monitored and data will be collected daily using an investigation guide of the first day of admission and will be included in group 1 or 2, from the first use of omeprazole to discontinuation (washout period of seven half-lives or higher). National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) algorithm will be used for causality analysis is used. Data will be tabulated according to the presence or absence of effectiveness and the presence or absence adverse events in the three groups. The odds ratio of adverse events and effectiveness of indicated and approve or not indicated and not approved prophylactic use of omeprazole will be calculated. Expected results. It is intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with or without indication or use approval, and the potential indications, dosage and unapproved methods of prophylactic use in omeprazole label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients will be separated into three groups: those who make indicated and approved prophylactic use of omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use (exposed group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not make prophylactic use of omeprazole will be excluded. Patients will have their pharmacotherapy monitored and data will be collected daily using an investigation guide of the first day of admission and will be included in group 1 or 2, from the first use of omeprazole to discontinuation (washout period of seven half-lives or higher).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients in use of omeprazole prophylactic (off label or indicated use) who will be admitted at the hospital under study,\n\nExclusion Criteria: Patients transferred from another hospital or ward; those with prescheduled surgery; those unable to communicate (intubated, in isolation, or mentally disoriented); and those with a hospital stay ≤24 hours.'}, 'identificationModule': {'nctId': 'NCT02278432', 'briefTitle': 'Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense', 'orgStudyIdInfo': {'id': '28217914.6.0000.5426'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patricia C Mastroianni, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'School of Pharmaceutical Sciences- Unesp'}, {'name': 'Tales R De Nadai, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Estadual de Américo Brasiliense'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Estadual Américo Brasiliense', 'class': 'UNKNOWN'}, {'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree student", 'investigatorFullName': 'Samir Antonio Rodrigues Abjaude', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}