Peptic Ulcer DiseaseEtaliepre-IPPNCT05618249
Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age
An observational study of Peptic Ulcer Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Peptic Ulcer Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 Aug 2020
- 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
- Older adult
Study population: Patient, over 75 years of age, with a PPI in the initial prescription
Who may be able to join
- Patient over 75 years of age
- Patient with a PPI in the initial prescription
- Patient seen at least once between 01/01/2018 and 31/11/2019 in the general practice
- Patient who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research.
Who cannot join
- Patient having expressed his opposition to participate in the study
- Impossibility to give the patient informed information (difficulties in understanding the subject, ...)
- Patient under legal protection
- Patient under guardianship or curatorship
- Patient who is no longer followed up in the office following an entry into an institution (EHPAD)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gériatrie - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age When Taking Over a Patient Base in the SOULTZ Haut-Rhin Sector
This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018.
It aims to highlight and quantify a possible inappropriate use of PPIs in private practice.
- Conditions
- Peptic Ulcer Disease
- Keywords
- Peptic Ulcer Disease, Proton pump inhibitors, PPI
- Medical subject headings
- Peptic Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective systematic analysis of patient prescriptions to identify possible inappropriate use of PPIs in private practice
Measured: Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618249
- Sponsor's protocol ID
- 7600
- Acronym
- Etaliepre-IPP
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age When Taking Over a Patient Base in the SOULTZ Haut-Rhin Sector
- ClinicalTrials.gov ID
- NCT05618249
- Acronym / sponsor ID
- Etaliepre-IPP / 7600
- Conditions
- Peptic Ulcer Disease
- Keywords
- Peptic Ulcer Disease, Proton pump inhibitors, PPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 16 Nov 2022 (actual)
- 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.
This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018.
It aims to highlight and quantify a possible inappropriate use of PPIs in private practice.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patient, over 75 years of age, with a PPI in the initial prescription
Key inclusion criteria (4 listed)
- Patient over 75 years of age
- Patient with a PPI in the initial prescription
- Patient seen at least once between 01/01/2018 and 31/11/2019 in the general practice
- Patient who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research.
Key exclusion criteria (5 listed)
- Patient having expressed his opposition to participate in the study
- Impossibility to give the patient informed information (difficulties in understanding the subject, ...)
- Patient under legal protection
- Patient under guardianship or curatorship
- Patient who is no longer followed up in the office following an entry into an institution (EHPAD)
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
Retrospective systematic analysis of patient prescriptions to identify possible inappropriate use of PPIs in private practice
Time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined
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 15 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Peptic Ulcer Disease, run by University Hospital, Strasbourg, France 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 5 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 15 Dec 2023. 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?
Retrospective systematic analysis of patient prescriptions to identify possible inappropriate use of PPIs in private practice (time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined). 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 15 Dec 2023.