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Clinical Trials in Switzerland / NCT06129474
Recruiting Not applicable

Deprescribing Inappropriate Proton Pump Inhibitors

NCT06129474 · tracked via the Priya Life Science Switzerland tracker
Sponsor
University of Bern
Phase
Not applicable
Started
2024-10-01
Last updated
2026-05-14

Condition(s) studied

Inappropriate PrescribingReflux DiseaseProton Pump Inhibitors

Investigational drug(s) / intervention(s)

Proton Pump Inhibitor deprescribing tool

Proton Pump Inhibitor deprescribing tool: The intervention is targeted to the Swiss Primary care practice. It involves educational material and resources to guide the safe deprescribing of inappropriate PPIs, for both general practitioners and patients.

Study 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 inappropriate proton-pump inhibitors (PPIs). Therefore, the trial investigates whether the study intervention leads to the deprescribing of inappropriate PPI prescription while ensuring noninferiority safety, in comparison to usual care. Additionally, the trail aims to investigate the intervention's impact on other clinical aspects, as well as addressing features of the implementation of the intervention and its cost-effectiveness.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient of a participating GP. 2. Age: minimum 18 years old. 3. Daily PPI intake for minimum 8 weeks. 4. PPI in one of the following doses: * minimum 40mg/day pantoprazole; * minimum 40mg/day omeprazole; * more than 30mg/day lansoprazole; * more than 30mg/day dexlansoprazole; * more than 20mg/day esomeprazole; * more than 20mg/day rabeprazole. 5. Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment. Exclusion Criteria: 1. Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy of less than 12 months. 2. Unable to provide informed consent. 3. 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.) 4. Two or more of the following medications, or one of the following medications and one or more of the mentioned risk factors mentioned below. Medications (any dose): * Daily use of non-steroidal anti-inflammatory drug (NSAID) for more than 7 days. * Antiplatelet therapy. * Additional antiplatelet therapy (e.g., ticagrelor or similar). * Anticoagulant(s). * Systemic steroid(s) for more than 1 month. Risk factors: * History of gastrointestinal ulcer. * Age of 75 years and older. * 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).

Primary outcome measure(s)

  • Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint). — 12 months
  • Safety co-primary endpoint: upper gastrointestinal symptoms (Non-inferiority endpoint) — 12 months
    Co-primary endpoints measured by the Reflux Disease Questionnaire (RDQ), considering the worst of the subscales dyspepsia and gastroesophageal reflux disease (GERD) (i.e.,regurgitation and heartburn subscales combined).

Trial sites (2)

FacilityCityRegionStatus
Prof. Dr. med. Dr. phil. Sven Streit Bern Switzerland Not Yet Recruiting
University of Bern Bern Switzerland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06129474 on ClinicalTrials.gov ↗ ← All trials in Switzerland