NCT06129474 Deprescribing Inappropriate Proton Pump Inhibitors
| NCT ID | NCT06129474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Inappropriate Prescribing |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-10-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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).
Contact & Investigator
Sven Streit, Prof. Dr. med. Dr. phil
PRINCIPAL INVESTIGATOR
University of Bern, Institute of Primary Health Care (BIHAM)
Frequently Asked Questions
Who can join the NCT06129474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inappropriate Prescribing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06129474 currently recruiting?
Yes, NCT06129474 is actively recruiting participants. Contact the research team at sven.streit@unibe.ch for enrollment information.
Where is the NCT06129474 trial being conducted?
This trial is being conducted at Bern, Switzerland, Bern, Switzerland.
Who is sponsoring the NCT06129474 clinical trial?
NCT06129474 is sponsored by University of Bern. The principal investigator is Sven Streit, Prof. Dr. med. Dr. phil at University of Bern, Institute of Primary Health Care (BIHAM). The trial plans to enroll 400 participants.