Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Cirrhosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study participants are randomized 1:1 to either discontinue their previous PPI therapy and replace it with placebo (intervention group) or continue pre-existing PPI therapy with esomeprazole 20mg/day. Details for the dose tapering phase are described below.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blinding is reached through over-encapsulation of the IMP, as well as identical drug packaging in both study arms.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04448028
- Collaborators
- German Federal Ministry of Education and Research
- University Hospital Heidelberg
- Investigators
- Study Chair: Ansgar W Lohse, MD I. Department of Medicine, University Medical Center Hamburg-Eppendorf Principal Investigator: Johannes Kluwe, MD I. Department of Medicine, University Medical Center Hamburg-Eppendorf