Proton Pump InhibitorEGERIPP 2NCT03980899
Evaluation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication
An observational study of Proton Pump Inhibitor, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proton Pump Inhibitor
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2019to 26 Apr 2023
- How long will I take part?
- 3 Months
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient admitted in Leopold Bellan post acute an rehabilitation institution.
Who may be able to join
- patients hospitalized in post acute and rehabilitation service
- more than 65 years old
- French-speaking patient
- Patients with PPI* in their SSRG entry treatment in an indication not recognized by the HAS and which has therefore been stopped (according to the service protocol)
Who cannot join
- Patient with a justified indication of PPI (recognized by the HAS)
- Patient receiving an IVSE PPI (pantoprazole 8mg/h) for suspected GI bleeding, even if not proven.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under the protection of justice
- Patient opposing participation in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Valuation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication
Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome.
Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009.
Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.
Read the detailed description
Professor Sylvie Legrain, in a 2005 HAS report, described that "Better prescribing in the elderly is thus a public health issue. "Indeed, although multi-medication in the elderly is often justified, it increases the risk of drug iatrogeny, reduces compliance and has a significant cost to society. In this report, it is specified that digestive tract drugs (including PPIs) represent the 3rd most prescribed class of drugs for people over 65 years of age (17% of patients use them regularly). PPIs are also mentioned in this report as overuse (overtreatment).
The first study, conducted in 2017 at our centre (EGERIPP), sought to assess whether a rebound effect was observed in patients who stopped PPI therapy (if not indicated). In this study, 30 patients were included and no rebound effects were observed. Five patients resumed PPIs out of the 30 patients included (unexplored anemia - n=1, epigastric pain - n=1, gastroesophageal reflux disease - n=1, no justification found - n=2). For all patients, during reassessment on D14 and D21 (during hospitalization), patients did not report more symptoms after discontinuation. In this context, the investigators now wish to study whether the short-term tolerance is prolonged in the long term for the discontinuation of PPIs.
This first study also allowed us to assess the prevalence of PPI use in the elderly, and the prevalence of patients on PPI for a recognized indication. During the study, 270 patients were screened and 76 patients had a PPI at admission (28%). Of these 76 patients, no indication recognized by the HAS was found in the medical file for 63 patients (83%).
The discontinuation of PPI treatments in case of use outside the recommendations is usually carried out in the department where the study is being conducted. There is therefore no change in practices. On the other hand, it is good practice to discontinue a treatment that is prescribed outside the recommendations.
Following the EGERIPP study, the systematic reassessment of PPI treatments has become a service practice, with discontinuation when no recognized indication is found and prescription of antacids on demand.
- Conditions
- Proton Pump Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PPI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with one or more of symptoms at Month 3
Percentage of patients with one or more of the following symptoms at Month 3 after PPI discontinuation: dyspepsia, reflux, heartburn, persistent dry cough, gastralgia (symptoms expected when PPI discontinuation occurs)
Measured: 3 months after end of treatment
Secondary outcomes (5)
Percentage of patients who have experienced one or more symptoms
Percentage of patients who have experienced one or more of the following symptoms since stopping: dyspepsia, reflux, heartburn, persistent dry cough and/or gastralgia.
Measured: 14 days after end of treatment
Cumulative number of antacid intakes within 14 days of stopping PPIs
Measured: 14 days after end of treatment
Comparaison of percentage
comparison of the:
- Percentage of patients who experienced at least one of the above symptoms
- Percentage of patients who felt they had experienced more of these symptoms
Measured: Day 14 and Month 3
Proportion of patients who resumed PPI treatment and reason for resumption
Measured: Day 14 and Month 3
Proportion of patients for whom the use of PPIs and their drug treatments in general is "very high" or "very important"
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start4 Jul 2019
- Primary completion3 Nov 2020
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton Pump InhibitorStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard P DURAND GASSELIN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980899
- Sponsor's protocol ID
- EGERIPP 2
- Acronym
- EGERIPP 2
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2019
- Last updated
- 27 Apr 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication
- ClinicalTrials.gov ID
- NCT03980899
- Acronym / sponsor ID
- EGERIPP 2 / EGERIPP 2
- Conditions
- Proton Pump Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 10 Jun 2019 (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.
Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome.
Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009.
Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.
Detailed description
Professor Sylvie Legrain, in a 2005 HAS report, described that "Better prescribing in the elderly is thus a public health issue. "Indeed, although multi-medication in the elderly is often justified, it increases the risk of drug iatrogeny, reduces compliance and has a significant cost to society. In this report, it is specified that digestive tract drugs (including PPIs) represent the 3rd most prescribed class of drugs for people over 65 years of age (17% of patients use them regularly). PPIs are also mentioned in this report as overuse (overtreatment).
The first study, conducted in 2017 at our centre (EGERIPP), sought to assess whether a rebound effect was observed in patients who stopped PPI therapy (if not indicated). In this study, 30 patients were included and no rebound effects were observed. Five patients resumed PPIs out of the 30 patients included (unexplored anemia - n=1, epigastric pain - n=1, gastroesophageal reflux disease - n=1, no justification found - n=2). For all patients, during reassessment on D14 and D21 (during hospitalization), patients did not report more symptoms after discontinuation. In this context, the investigators now wish to study whether the short-term tolerance is prolonged in the long term for the discontinuation of PPIs.
This first study also allowed us to assess the prevalence of PPI use in the elderly, and the prevalence of patients on PPI for a recognized indication. During the study, 270 patients were screened and 76 patients had a PPI at admission (28%). Of these 76 patients, no indication recognized by the HAS was found in the medical file for 63 patients (83%).
The discontinuation of PPI treatments in case of use outside the recommendations is usually carried out in the department where the study is being conducted. There is therefore no change in practices. On the other hand, it is good practice to discontinue a treatment that is prescribed outside the recommendations.
Following the EGERIPP study, the systematic reassessment of PPI treatments has become a service practice, with discontinuation when no recognized indication is found and prescription of antacids on demand.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PPI | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient admitted in Leopold Bellan post acute an rehabilitation institution.
Key inclusion criteria (4 listed)
- patients hospitalized in post acute and rehabilitation service
- more than 65 years old
- French-speaking patient
- Patients with PPI* in their SSRG entry treatment in an indication not recognized by the HAS and which has therefore been stopped (according to the service protocol)
Key exclusion criteria (6 listed)
- Patient with a justified indication of PPI (recognized by the HAS)
- Patient receiving an IVSE PPI (pantoprazole 8mg/h) for suspected GI bleeding, even if not proven.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under the protection of justice
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
Percentage of patients with one or more of symptoms at Month 3
Time frame: 3 months after end of treatment
Percentage of patients with one or more of the following symptoms at Month 3 after PPI discontinuation: dyspepsia, reflux, heartburn, persistent dry cough, gastralgia (symptoms expected when PPI discontinuation occurs)
5 secondary outcomes
Percentage of patients who have experienced one or more symptoms
Time frame: 14 days after end of treatment
Cumulative number of antacid intakes within 14 days of stopping PPIs
Time frame: 14 days after end of treatment
Comparaison of percentage
Time frame: Day 14 and Month 3
Proportion of patients who resumed PPI treatment and reason for resumption
Time frame: Day 14 and Month 3
Proportion of patients for whom the use of PPIs and their drug treatments in general is "very high" or "very important"
Time frame: Month 3
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 27 Apr 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.
Bernard P DURAND GASSELIN, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Proton Pump Inhibitor, run by Fondation Hôpital Saint-Joseph 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 6 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 27 Apr 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?
Percentage of patients with one or more of symptoms at Month 3 (time frame: 3 months after end of treatment). 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 27 Apr 2023.