A Phase 4 interventional study of de-prescription of PPI via intermittent scheme and de-prescription of PPI via on-demand scheme in Heartburn, Dyspepsia and Reflux, sponsored by Universitaire Ziekenhuizen KU Leuven. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
Proton pump inibitors (PPIs) is a class of medications that reduce the acid secretion in the stomach. These medications are very effective to relieve symptoms of acid reflux for a well-identified group of diseases and conditions.
Over the years, a major rise in use of these drugs has occurred. Convincing analyses reveal that a large share of this use occurs outside regular indications, at inappropriately elevated doses and prolonged treatment durations. Moreover, there are increasing concerns regarding potential adverse effects and the high cost associated with improper PPI use.
Guidelines propose to reduce chronic use of PPIs, but to date this has not generated a reduction in their application in clinical practice. One reason is the occurrence of a period of 2 weeks of increased acid secretion, with recurrence of symptoms, when these drugs are stopped after already a few weeks of usage (rebound effect). The best strategy to overcome this period of increased acid secretion and symptoms has not been established.
The PEPPER study will evaluate two different strategies to overcome the period of increased secretion when trying to interrupt chronic proton pump inhibitor therapy. The investigators will compare the success of stopping PPIs when these strategies are implemented, compared to a classical strategy of stopping after intermittent PPI intake. The strategies under evaluation are a period of non-daily intake of proton pump inhibitors (on-demand) before stopping, or the use of alternative methods to control gastric acidity and reflux (so-called alginates).
The investigators will evaluate the success rate of stopping chronic PPIs treatment with these approaches, compared to an interruption with intake of antacids. Patients will be followed up for 1 year after interruption of PPIs, and the level of symptom control, quality of life and healthcare costs will be evaluated at intervals.
The study will be conducted in patients from primary care practices with chronic PPIs intake outside of the established disease indications.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's planned enrollment of 724 is above the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible patients are those of either gender, above the age of 18, eligible to give
Based on dose:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Classical approach for deprescribing of PPI based on Belgian Guidelines. In this study arm, the patients will keep the intake of their PPI but will decrease the use of PPI using a scheme where the PPI dose in reduced intermittently for one month. After one month in the intermittent deprescribing scheme, the patients will stop the use of PPI.
Procedure: de-prescription of PPI via intermittent scheme
In this study arm, the patients will keep the intake of their PPI but will decrease the use of PPI in an on-demand bases for one month. The patient will only take the PPI when strictly needed because of symptoms. After one month in the on-demand PPI use, the patients will stop the use of PPI.
Procedure: de-prescription of PPI via on-demand scheme
In this study arm, the patient will stop the intake of the PPI band replace it with the use of an alginate for one month. After one month, the patient will stop the use of alginates.
Drug: Alginate
The patients will decrease their intake of PPIs via a de-prescription intermittent scheme. After one month, patients will stop their intake of PPI.
The patients will decrease their intake of PPIs via a de-prescription on-demand scheme. After one month, patients will stop their intake of PPI.
Drug pages: Alginates · Alginic Acid
The patients will stop their intake of PPIs and use alginate. After one month, patients will stop their intake of alginates.
Succes of de-prescription strategy
percentage of randomized patients achieving successful therapeutic outcome at the end of the follow up period in each treatment group
Time frame: 15 months
Use of PPI
Patient reported outcome The use of PPI will be reported by the patient at each study visit as adherence to the suggested treatment. As this information is considered as standard of care, this is the value that will be used for the analysis of this first key point that will be used for the assessment of the primary endpoint of the study. During follow up, patients taking at least one dose of PPIs weekly will be consider as active PPI users, and therefore a failure to this key indicator (result "0"). If patients report to have used a dose PPI less than 3 times in a month, this subject will not be consider as clinical relevant users, and therefore the key indicator result is positive and "1".
Time frame: 15 months
Treatment satisfaction
Patient reported outcome Scale title:treatment satisfaction scale Question to assess treatment satisfaction is: "How satisfied or dissatisfied are you with the control of your symptoms with the current treatment?" Minimum and maximum values: seven-point bipolar scale from 'Extremely Satisfied' (score 7) to 'Extremely Dissatisfied' (score 1) Higher scores mean: better outcome
Time frame: 15 months
Willingness to continue with the current treatment
Patient reported outcome To assess willingness to continue to current treatment regimen, the following question will be used: "Would you be willing to continue the current treatment for the next month?"
Time frame: 15 months
Economic impact of PPI deprescribing
Title: Health resource utilisation questionnaire Minimum and maximum values: yes or no questions (1 or 0) regarding use health resource use Higher scores mean: worst outcome as this is related to more expences due to health issues
Time frame: 15 months
Predictor of success - Predictive value of the symptom pattern
Patient reported outcome questionnaire title:esophageal and gastric symptoms questionnaire Min and max values: varies based on the question to presence of a symptom: yes-no questions and the severity of symptoms with higher scores for more severe symptoms. Higher scores means worst outcome as symptoms are more present and more severe.
Time frame: 15 months
Predictive value of demographic variables
Demographic assessment with patients questionnaires
Time frame: 15 month
Predictive value of number of co-morbidities to stop PPIs use
Co-morbidities assessment via GP via eCRF The investigator will evaluate if increased number of co-morbidities is a predictor for lower likelihood to succeed a the treatment to decrease the use of PPI.
Time frame: 15 months
Predictive value of number of previous failed attempts to stop PPIs use
Assessment via eCRF via GP medical assessment The investigator will evaluate if the number of previous failed attempts to stop PPIs use is a predictor for lower likelihood to succeed a the treatment to decrease the use of PPI.
Time frame: 15 months
Predictive value of gastrin level
Blood sample at baseline and after 1 year follow-up
Time frame: 15 months
Predictive value of the level of patients' motivation to stop PPIs use
Patient reported outcome on motivation during the study title: Motivational visual analogue scale Max-min scores: 100-0 from "extremely motivated" to "no motivation" Higher scores: good outcome The investigator will evaluate if the level of motivation to stop PPIs use is a predictor for likelihood to succeed a the treatment to decrease the use of PPI.
Time frame: 15 months
Work productivity impact of PPI deprescribing
title: Work productivity impact questionnaire (WPAI) Max-Min scores: yes/no questions (1/0) and number of hours worked per week (scores: 0 to 150) Higer scores= good outcome, as the patients feels good to work and be productive
Time frame: 15 months
Number of participants using rescue therapy
Assessment via questionnaire in ePRO
Time frame: 15 months
Plan to share: No — no individual data sharing
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Mar 2026, 33 months after the start.
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alginates · Alginic Acid
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