Proton Pump InhibitorNCT03467893
Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor in Geriatric Population
An observational study of Proton Pump Inhibitor, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proton Pump Inhibitor
- What is being tested?
- Antacids
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2017to 28 Feb 2018
- 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
- PPI prescription more than 8 weeks
Who cannot join
- PPI prescription under 8 weeks
- PPI prescription for digestive haemorragy
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: Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor After 8 Weeks of Treatment in Geriatric Population
Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. The fact is that multi medication in old patient increase the iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are overused in this patient category.Several studies suggest the existence of a rebound effect when people were treated more than 8 weeks ; this effect seems to appear around 14 days after with hyperacidity symptoms.
But there are no studies about old patient. So in this context the aim of the study is to evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.
- Conditions
- Proton Pump Inhibitor
- Being tested
- Antacids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntacidsDrug
number aof antacids treatment after PPI stop
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of antacids used
Measured: Day 14 after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start10 Jun 2017
- Primary completion1 Jul 2017
- Study completion28 Feb 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467893
- Sponsor's protocol ID
- EGERIPP
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 6 Aug 2019
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor After 8 Weeks of Treatment in Geriatric Population
- ClinicalTrials.gov ID
- NCT03467893
- Acronym / sponsor ID
- EGERIPP
- Conditions
- Proton Pump Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 16 Mar 2018 (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 inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. The fact is that multi medication in old patient increase the iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are overused in this patient category.Several studies suggest the existence of a rebound effect when people were treated more than 8 weeks ; this effect seems to appear around 14 days after with hyperacidity symptoms.
But there are no studies about old patient. So in this context the aim of the study is to evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 (3 listed)
- patients hospitalized in post acute and rehabilitation service
- more than 65 years old
- PPI prescription more than 8 weeks
Key exclusion criteria (2 listed)
- PPI prescription under 8 weeks
- PPI prescription for digestive haemorragy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antacidsnumber aof antacids treatment after PPI stop | Drug | – |
Primary outcome
Number of antacids used
Time frame: Day 14 after end of treatment
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 6 Aug 2019.
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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 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 3 inclusion and 2 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 6 Aug 2019. 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?
Number of antacids used (time frame: Day 14 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 6 Aug 2019.