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Determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients: impact of on-demand use, adjustment of therapy or discontinuation.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502375-37-00
Acronym
PEPPER
Enrollment
745
Registered
2023-04-12
Start date
2023-04-16
Completion date
Unknown
Last updated
2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia, heartburn, reflux

Brief summary

the percentage of randomized patients achieving successful therapeutic outcome at the end of the follow up period in each treatment group. Successful therapeutic outcome is determined by the sum of the predefined 3 key points reported by the patient (the use of PPI, treatment satisfaction and willingness to continue with the treatment) during the follow up period.

Detailed description

For each study visit the result of each key indicator to achieve therapeutic success (separate PPI discontinuation, treatment satisfaction and willingness to continue) will be evaluated., For each study visit, the percentage of successful therapeutic outcome (sum of 3 key indicators, as defined for the primary outcome) will be evaluated., The percentage of weeks during the follow up period in which patients did not use PPI.

Interventions

DRUGMaalox Antacid® Citroen 230 mg/400 mg per 4
DRUG3 ml suspensie voor oraal gebruik
DRUGGaviscon Antizuur - Antireflux Unidose 500mg/213mg/325mg suspensie voor oraal gebruik in sachet.
DRUGMaalox Antacid® Suikervrij Citroen 200 mg/400 mg kauwtabletten
DRUGMaalox Antacid® 230mg/400 mg par 10 ml suspension buvable
DRUGMaalox Antacid® 200 mg/400 mg kauwtabletten

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the percentage of randomized patients achieving successful therapeutic outcome at the end of the follow up period in each treatment group. Successful therapeutic outcome is determined by the sum of the predefined 3 key points reported by the patient (the use of PPI, treatment satisfaction and willingness to continue with the treatment) during the follow up period.

Secondary

MeasureTime frame
For each study visit the result of each key indicator to achieve therapeutic success (separate PPI discontinuation, treatment satisfaction and willingness to continue) will be evaluated., For each study visit, the percentage of successful therapeutic outcome (sum of 3 key indicators, as defined for the primary outcome) will be evaluated., The percentage of weeks during the follow up period in which patients did not use PPI.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 19, 2026