Proton Pump Inhibitor Treatment Stop

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.

This is evaluated in a discontinuation trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

NCT00363701

Dyspepsia Gastroesophageal Refluxdisease Ulcer

UNKNOWN PHASE4

PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

NCT00526006

Healthy

UNKNOWN PHASE4

Primary carE PPi dEprescRibing Trial

NCT05629143

Heartburn Dyspepsia Reflux

ACTIVE_NOT_RECRUITING PHASE4

Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

NCT00915239

Healthy

COMPLETED NA

Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial

NCT05348252

Proton Pump Inhibitor Inappropriate Drug Use Discontinuation +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background:

Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.

Aim/purpose:

It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.

Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.

Methods:

To conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. Long-term use is defined as treatment for more than 2x28 days during a 6-month period. The patients are included with a 13C-urea Hp-breath test and randomised for treatment with PPI or placebo. Hp-positive patients are treated with an Hp-eradication treatment. The patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. The patients are to fill in a symptom and medication diary every month for periods of 1 week. Questionnaires are to be given to the patients 3 times during the follow-up period. Medication diaries as well as questionnaires have proven useful in similar studies. The main outcome is analysed using Kaplan-Meier survival estimates analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspepsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

esomeprazole

Long-term users continue antisecretory medication

Group Type NO_INTERVENTION

esomeprazole

Intervention Type DRUG

esomeprazole, original Nexium, 40 mg pills Up to once a day

Helicobacter pylori c-13 breath test

Intervention Type PROCEDURE

Breath test done at entry to find Helicobacter pylori

placebo drug

Long-term users are treated with placebo

Group Type PLACEBO_COMPARATOR

esomeprazole

Intervention Type DRUG

esomeprazole, original Nexium, 40 mg pills Up to once a day

Helicobacter pylori c-13 breath test

Intervention Type PROCEDURE

Breath test done at entry to find Helicobacter pylori

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

esomeprazole

esomeprazole, original Nexium, 40 mg pills Up to once a day

Intervention Type DRUG

Helicobacter pylori c-13 breath test

Breath test done at entry to find Helicobacter pylori

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Use of antisecretory medication for more than 2 months during the last 6 months

Exclusion Criteria

* Malignity or severe, competing medical or psychiatric disease
* Esophagitis (proven by endoscopy)
* Prior complication to peptic ulcer disease
* Alarm symptoms
* Pregnancy or lactation
* Allergy towards esomeprazole
* Planned hospitalisation during study period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No