Clinical trial NCT02278432: Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Official title: Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Omeprazole
Keywords: risk assessment
pharmacovigilance
pharmacoepidemiology
drug toxicity
adverse drug reaction reporting system
omeprazole
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Hospital Estadual Américo Brasiliense
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2014-10-30
Enrollment: 427
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Assessment magnesium serum level
timeFrame: at least one day
measure: Assessment of creatinine serum level
timeFrame: at least one day
measure: Assessment of urea serum level
timeFrame: at least one day
Secondary outcomes:
measure: Assessment of omeprazole effectiveness and adverse drug reaction
timeFrame: at least one day
Other outcomes:
Locations:
Study officials:
affiliation: School of Pharmaceutical Sciences- Unesp
name: Patricia C Mastroianni, PHD
role: STUDY_CHAIR
affiliation: Hospital Estadual de Américo Brasiliense
name: Tales R De Nadai, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.