Primary carE PPi dEprescRibing (PEPPER) trial

Phase 1

Recruiting

• Conditions: heartburn, Functional dyspepsia, reflux; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2022-502375-37-00
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 745

Inclusion 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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified