OmeprazoleNCT02278432
Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
An observational study of Omeprazole, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Omeprazole
- How many people
- 427 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
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.
About this study
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
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment magnesium serum level
Level magnesium serum will be considered normal when ranged among 1.9 to 2.5 mg/dL.
Measured: 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.
Measured: at least one day
Assessment of urea serum level
Urea serum level will be considered normal when ranged among 15 a 45 mg/dL
Measured: at least one day
Secondary outcomes (1)
Assessment of omeprazole effectiveness and adverse drug reaction
Effectiveness and safety of omeprazole are going to be performed by patient report and analysis of medical records.
Measured: at least one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OmeprazoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Estadual Américo Brasiliense, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Samir Antonio Rodrigues Abjaude, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Patricia C Mastroianni, PHD, Study chair, School of Pharmaceutical Sciences- UnespTales R De Nadai, PhD, Study chair, Hospital Estadual de Américo Brasiliense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278432
- Sponsor's protocol ID
- 28217914.6.0000.5426
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24626940Talley 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.
PubMed 19203303Faulhaber 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.
PubMed 23680271Ameijeiras 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.
PubMed 17916308Varallo 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.
PubMed 29759903
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
- ClinicalTrials.gov ID
- NCT02278432
- Acronym / sponsor ID
- 28217914.6.0000.5426
- Conditions
- Omeprazole
- Keywords
- risk assessment, pharmacovigilance, pharmacoepidemiology, drug toxicity, adverse drug reaction reporting system, omeprazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Hospital Estadual Américo Brasiliense, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
1 secondary outcome
Assessment of omeprazole effectiveness and adverse drug reaction
Time frame: at least one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Background: PubMed 24626940Varallo 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.
- Background: PubMed 19203303Talley 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.
- Background: PubMed 23680271Faulhaber 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.
- Background: PubMed 17916308Ameijeiras 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.
- Derived from this study: PubMed 29759903Varallo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia C Mastroianni, PHD study chair
School of Pharmaceutical Sciences- Unesp
Tales R De Nadai, PhD study chair
Hospital Estadual de Américo Brasiliense
Questions about this trial
What is this clinical trial studying?
An observational study of Omeprazole, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment magnesium serum level (time frame: at least one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278432, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.