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Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense

NCT02278432 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 427

Last updated 2015-10-20

No results posted yet for this study

Summary

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.

Conditions

  • Omeprazole

Sponsors & Collaborators

  • Hospital Estadual Américo Brasiliense

    collaborator UNKNOWN

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    lead OTHER

Principal Investigators

  • Patricia C Mastroianni, PHD · School of Pharmaceutical Sciences- Unesp

  • Tales R De Nadai, PhD · Hospital Estadual de Américo Brasiliense

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-11-30
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278432 on ClinicalTrials.gov