Geriatric DisorderIPP SANCT02841852
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients?
An observational study of Geriatric Disorder, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Disorder
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jul 2014
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients aged 75 and over hospitalized in acute geriatric medicine
Who may be able to join
- 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
Who cannot join
- Patients who have expressed their inability or refusal to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Geriatric Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of comorbidities
Burden of comorbidities is assessed by the CIRS (Cumulative Illness Rating Scale)
Measured: 48 hours after the entry into acute geriatric medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure De DECKER, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841852
- Sponsor's protocol ID
- RC13_0262
- Acronym
- IPP SA
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients Over 75 Years Old ?
- ClinicalTrials.gov ID
- NCT02841852
- Acronym / sponsor ID
- IPP SA / RC13_0262
- Conditions
- Geriatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Jul 2016 (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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients aged 75 and over hospitalized in acute geriatric medicine
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have expressed their inability or refusal to sign an informed consent
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
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)
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 26 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Laure De DECKER, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Disorder, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Burden of comorbidities (time frame: 48 hours after the entry into acute geriatric medicine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.