Proton Pump Inhibitor Treatment Stop

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Dyspepsia

Treatments: Drug: esomeprazole; Procedure: Helicobacter pylori c-13 breath test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00120315

02.04

2612-2176

VF 20020212

D9612L00060

MPU 16-2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 2 patient groups, including a placebo group

esomeprazole

No Intervention group

Description:

Long-term users continue antisecretory medication

Treatment:

Procedure: Helicobacter pylori c-13 breath test

Drug: esomeprazole

placebo drug

Placebo Comparator group

Description:

Long-term users are treated with placebo

Treatment:

Procedure: Helicobacter pylori c-13 breath test

Drug: esomeprazole