Primary carE PPi dEprescRibing Trial (PEPPER)
Heartburn, Dyspepsia, Reflux
About this trial
This is an interventional treatment trial for Heartburn focused on measuring proton pump inhibitor
Eligibility Criteria
Inclusion Criteria: Eligible patients are those of either gender, above the age of 18, eligible to give informed consent Based on indication: Patients on long-term (>12 weeks) chronic (daily) PPI use without therapy indication are eligible to participate. Based on dose: Patients on a "maintenance" PPI dose are eligible for randomization. Maintenance dose is 20 mg of omeprazole, esomeprazole or pantoprazole daily or 15 mg of lansoprazole daily or 10 mg of rabeprazole daily. Patients on a "healing" PPI dose (i.e. ≥40 mg esomeprazole, esomeprazole or pantoprazole or ≥30 mg of lansoprazole or ≥20 mg or rabeprazole daily) are also eligible, but need first to down-titrate their dose to "maintenance" dose before they can be considered for randomization. Exclusion Criteria: Patients on short-term (<12 weeks) PPI therapy. Patients not on chronic PPI use (less than daily intake) Patients with established long-term indication such as the presence of a grade C, D oesophagitis, a peptic ulcer, Barrett's oesophagus or Zollinger-Ellison syndrome. Patients with chronic use of Gaviscon® or similar drugs based on magaldrate such as Riopan® and Gastricalm® (i.e. more than once a week for the last 2 months). Patients with chronic use of NSAIDs (i.e. two or more weekly doses). Patients with a history of gastric or oesophageal surgery. Patients with a major oesophageal disease such as achalasia, oesophageal spasm, or oesophageal involvement in systemic disease such as scleroderma or dermatomyositis. Patients with drug abuse and/or alcohol abuse Women who are pregnant or lactating Patients not able to understand or be compliant with the study.
Sites / Locations
- Jan Tack
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Intermittent deprescribing strategy
On-demand deprescribing strategy
Replacement of PPI with alginate therapy
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.
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.
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.