Proton Pump Inhibitor Treatment Stop

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: esomeprazole
* Procedure: Helicobacter pylori c-13 breath test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: esomeprazole<br>Long-term users continue antisecretory medication | Drug: esomeprazole<br>* esomeprazole, original Nexium, 40 mg pills Up to once a day<br>Procedure: Helicobacter pylori c-13 breath test<br>* Breath test done at entry to find Helicobacter pylori<br>|
| Placebo Comparator: placebo drug<br>Long-term users are treated with placebo | Drug: esomeprazole<br>* esomeprazole, original Nexium, 40 mg pills Up to once a day<br>Procedure: Helicobacter pylori c-13 breath test<br>* Breath test done at entry to find Helicobacter pylori<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of patient perceived symptom control despite treatment with project medication |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspepsia, discontinuation, Primary health care, Helicobacter pylori, Proton Pump Inhibitor, Histamine-2-receptor-antagonist