Status:
RECRUITING
Deprescribing Inappropriate Proton Pump Inhibitors
Lead Sponsor:
University of Bern
Collaborating Sponsors:
Swiss National Science Foundation
University of Zurich
Conditions:
Inappropriate Prescribing
Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The DROPIT Trial is an interventional, open-labelled, cluster-randomized controlled trial conducted in the Swiss primary care setting. It aims to evaluate an intervention to guide the deprescribing of...
Detailed Description
Background and rational: Proton pump inhibitors (PPIs) are the most frequent treatment of gastric acid related disorders. The use of PPIs is increasing, as well as concerns about their inappropriate ...
Eligibility Criteria
Inclusion
- Patient of a participating GP.
- Age ≥18 years old.
- Daily PPI intake for ≥8 weeks.
- PPI twice a day or in a dose as:
- 40mg/day pantoprazole;
- 40mg/day omeprazole; \>30mg/day lansoprazole; \>30mg/day dexlansoprazole; \>20mg/day esomeprazole; \>20mg/day rabeprazole.
- Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.
Exclusion
- Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy \< 12 months.
- Unable to provide informed consent.
- PPI in an appropriate dose (see Appendix Table A1) and with an established indication for long-term PPI, such as:
- History of bleeding ulcer.
- Peptic ulcer due to cause other than NSAID or H. Pylori.
- Barrett's oesophagus.
- Severe erosive reflux disease (Los Angeles grade C/D).
- GERD with symptoms or complications (oesophageal ulcer, peptic stricture).
- Other indications (i.e., Zollinger-Ellison-Syndrome, PPI-sensitive eosinophilic esophagitis, chronic pancreatitis with steatorrhea refractory to enzyme replacement therapy, idiopathic pulmonary fibrosis.)
- Two or more of the following medications, or one of the following medications and one or more of the below risk factors.
- Medications (any dose):
- Daily use of non-steroidal anti-inflammatory drug (NSAID) \>7 days.
- Antiplatelet therapy.
- Additional antiplatelet therapy (e.g., ticagrelor or similar).
- Anticoagulant(s).
- Systemic steroid(s) \>1 month.
- Risk factors:
- History of gastrointestinal ulcer.
- Age ≥65 years.
- Selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) use.
- Severe concomitant disease with increased risk of GI bleeding according to the GP's assessment (e.g., severe liver disease, neoplasia, nicotine or alcohol abuse).
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06129474
Start Date
October 1 2024
End Date
December 31 2027
Last Update
November 21 2025
Active Locations (2)
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1
Prof. Dr. med. Dr. phil. Sven Streit
Bern, Switzerland, 3012
2
University of Bern
Bern, Switzerland, 3012