Primary carE PPi dEprescRibing (PEPPER) trial
EU CTIS ID: 2022-502375-37-00
What this study is testing
The study aims at determining the best de-prescribing strategy for proton pumps inhibitors (PPIs) in patients who are chronically using PPIs without an established indication for long-term use. The study will evaluate the success rate of two different approaches, (A) on-demand PPI use and (B) replacement of PPI therapy with an alginate formulation. Both approaches will be compared with the classical approach which is gradual decrease of PPI dose through fixed intermittent intake (C). It is hypothesized that the new deprescribing strategies A and B will be significantly better compared to the standard approach C. In addition, it is hypothesized that at the level of the new strategies, approach A will not be inferior than approach B.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- adults older than 18 years old
- male and females
- Patients on long-term (>12 weeks) chronic (daily) PPI use without therapy indication are eligible to participate.
You likely can't join if
- Patients on short-term (<12 weeks) PPI therapy
- Patients not able to understand or be compliant with the study.
- Patients not on chronic PPI use (less than 80% 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 long term chronic use of NSAIDs (i.e. two or more weekly doses).
See the full eligibility criteria
- adults older than 18 years old
- male and females
- Patients on long-term (>12 weeks) chronic (daily) PPI use without therapy indication are eligible to participate.
- Patients on short-term (<12 weeks) PPI therapy
- Patients not able to understand or be compliant with the study.
- Patients not on chronic PPI use (less than 80% 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 long term 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.