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

NCT02278432 | Completed

• 1 other identifier: 28217914.6.0000.5426
• Study Type: observational
• Target: 427
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Omeprazole

Keywords

risk assessment; pharmacovigilance; pharmacoepidemiology; drug toxicity; adverse drug reaction reporting system; omeprazole

Outcome Measures

Primary Outcomes (3)

• Assessment magnesium serum level

  Level magnesium serum will be considered normal when ranged among 1.9 to 2.5 mg/dL.

  at least one day

• Assessment of creatinine serum level

  Creatinine serum level will be considered normal when ranged among 0,5 a1,2 mg/dL.

  at least one day

• Assessment of urea serum level

  Urea serum level will be considered normal when ranged among 15 a 45 mg/dL

  at least one day

Secondary Outcomes (1)

• Assessment of omeprazole effectiveness and adverse drug reaction

  at least one day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Hospital Estadual Américo Brasiliense: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Related Publications (5)

• 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: 24626940 BACKGROUND

• 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: 19203303 BACKGROUND

• 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: 23680271 BACKGROUND

• 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: 17916308 BACKGROUND

• 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.

  PMID: 29759903 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Patricia C Mastroianni, PHD

  School of Pharmaceutical Sciences- Unesp

  STUDY CHAIR

• Tales R De Nadai, PhD

  Hospital Estadual de Américo Brasiliense

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10