Proton Pump Inhibitor Treatment Stop

Phase 4

Completed

• Conditions: Dyspepsia
• Interventions: Drug: esomeprazole; Procedure: Helicobacter pylori c-13 breath test

• Registration Number: NCT00120315
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-07-08
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-15
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-05
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esomeprazole	esomeprazole	Long-term users continue antisecretory medication
esomeprazole	Helicobacter pylori c-13 breath test	Long-term users continue antisecretory medication
placebo drug	esomeprazole	Long-term users are treated with placebo
placebo drug	Helicobacter pylori c-13 breath test	Long-term users are treated with placebo

Primary Outcome Measures

Name	Time	Method
Failure of patient perceived symptom control despite treatment with project medication	12 months

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	12 months
Quality of life	12 months
GPs and patients satisfaction	12 months
Helicobacter pylori status	At enrolement
Resource consumption	12 months
Days without symptoms	12 months
Use of otc-medication	12 months
Sick-leave days	12 months
Number of visits to primary and secondary healthcare system	12 months

Trial Locations

Locations (1)

Department of Medical Gastroenterology, Odense University Hospital; 🇩🇰 Odense, Denmark