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

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ClinicalTrials.gov Identifier: NCT02278432
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 20, 2015
Sponsor:
Collaborators:
Hospital Estadual Américo Brasiliense
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Samir Antonio Rodrigues Abjaude, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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.

Condition or disease
Omeprazole

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Study Type : Observational
Actual Enrollment : 427 participants
Time Perspective: Prospective
Official Title: Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Study Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Assessment magnesium serum level [ Time Frame: at least one day ]
    Level magnesium serum will be considered normal when ranged among 1.9 to 2.5 mg/dL.

  2. Assessment of creatinine serum level [ Time Frame: at least one day ]
    Creatinine serum level will be considered normal when ranged among 0,5 a1,2 mg/dL.

  3. Assessment of urea serum level [ Time Frame: at least one day ]
    Urea serum level will be considered normal when ranged among 15 a 45 mg/dL


Secondary Outcome Measures :
  1. Assessment of omeprazole effectiveness and adverse drug reaction [ Time Frame: at least one day ]
    Effectiveness and safety of omeprazole are going to be performed by patient report and analysis of medical records.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria: patients in use of omeprazole prophylactic (off label or indicated use) who will be admitted at the hospital under study,

Exclusion 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278432


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Hospital Estadual Américo Brasiliense
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Study Chair: Patricia C Mastroianni, PHD School of Pharmaceutical Sciences- Unesp
Study Chair: Tales R De Nadai, PhD Hospital Estadual de Américo Brasiliense

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samir Antonio Rodrigues Abjaude, Master's degree student, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02278432    
Other Study ID Numbers: 28217914.6.0000.5426
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Samir Antonio Rodrigues Abjaude, Universidade Estadual Paulista Júlio de Mesquita Filho:
risk assessment
pharmacovigilance
pharmacoepidemiology
drug toxicity
adverse drug reaction reporting system
omeprazole
Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action