- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841852
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients? (IPP SA)
July 25, 2016 updated by: Nantes University Hospital
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients Over 75 Years Old ?
Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in the world and the most effective drugs available to reduce gastric acid secretion.
However, studies have shown that PPIs are not always prescribed with a clear indication.
Indeed, between 25% and 86% of older individuals taking a PPI have been overprescribed these medications.
In older patients, overprescribing of a PPI is associated with increases in morbidity, adverse drug events, hospitalization, and mortality.
The hypothesis is that overprescription of PPIs is associated with the individual multimorbidities in older patients evaluated using the multimorbidities group criteria included in the CIRS.
The aim of the present study was to establish a relationship between overprescribing of PPIs and multimorbidities in older patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
280
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint Nazaire, France, 44606
- Centre Hospitalier de St Nazaire
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Older patients aged 75 and over hospitalized in acute geriatric medicine
Description
Inclusion Criteria:
- Patients of 75 years or more
- Patients hospitalized in geriatric short stay
- Patients with an inhibitor therapy proton pump short geriatric entry
- Patients who have given their written consent
Exclusion Criteria:
- Patients who have expressed their inability or refusal to sign an informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burden of comorbidities
Time Frame: 48 hours after the entry into acute geriatric medicine
|
Burden of comorbidities is assessed by the CIRS (Cumulative Illness Rating Scale)
|
48 hours after the entry into acute geriatric medicine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laure De DECKER, Dr, Nantes university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
July 20, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- RC13_0262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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