Primary carE PPi dEprescRibing (PEPPER) trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

16 Apr 2023 → 25 Mar 2026

Decision date (initial)

2023-04-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Federal research institute the Belgian Health Care Knowledge Centre

External identifiers

EU CT number

2022-502375-37-00

ClinicalTrials.gov

NCT05629143

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The study aims at determining the best de-prescribing strategy for proton pumps inhibitors (PPIs) in patients who are chronically using PPIs without an established indication for long-term use.

The study will evaluate the success rate of two different approaches, (A) on-demand PPI use and (B) replacement of PPI therapy with an alginate formulation. Both approaches will be compared with the classical approach which is gradual decrease of PPI dose through fixed intermittent intake (C).
It is hypothesized that the new deprescribing strategies A and B will be significantly better compared to the standard approach C. In addition, it is hypothesized that at the level of the new strategies, approach A will not be inferior than approach B.

Secondary objectives 1

1. Evaluation of different parameters to provide information on the time-course of success or failure of PPI deprescribing strategies

Conditions and MedDRA coding

heartburn

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. adults older than 18 years old
2. male and females
3. Patients on long-term (>12 weeks) chronic (daily) PPI use without therapy indication are eligible to participate.

Exclusion criteria 10

1. Patients on short-term (<12 weeks) PPI therapy
2. Patients not on chronic PPI use (less than 80% intake)
3. 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
4. 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).
5. Patients with long term chronic use of NSAIDs (i.e. two or more weekly doses).
6. Patients with a history of gastric or oesophageal surgery.
7. Patients with a major oesophageal disease such as achalasia, oesophageal spasm, or oesophageal involvement in systemic disease such as scleroderma or dermatomyositis.
8. Patients with drug abuse and/or alcohol abuse
9. Women who are pregnant or lactating
10. Patients not able to understand or be compliant with the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 3

1. 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.
2. For each study visit, the percentage of successful therapeutic outcome (sum of 3 key indicators, as defined for the primary outcome) will be evaluated.
3. The percentage of weeks during the follow up period in which patients did not use PPI.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Florencia Carbone

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Locations

1 EU/EEA country · 79 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications