Proton Pump Inhibitor Treatment Stop

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: esomeprazole; Procedure: Helicobacter pylori c-13 breath test

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 Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, DK-5000
    • Department of Medical Gastroenterology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	12 months
Gastrointestinal symptoms	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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: AstraZeneca; University of Southern Denmark; The Danish Medical Research Council; Danish College of General Practitioners; Research Unit of General Practice, Odense; Apotekerfonden af 1991
• Investigators: Study Director: Ove B Schaffalitzky de Muckadell, Professor, Odense University Hospital

Publications and helpful links

General Publications

• Zwisler JE, Jarbol DE, Lassen AT, Kragstrup J, Thorsgaard N, Schaffalitzky de Muckadell OB. Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice. Int J Family Med. 2015;2015:175436. doi: 10.1155/2015/175436. Epub 2015 Jul 12.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: July 8, 2005
• First Submitted That Met QC Criteria: July 8, 2005
• First Posted (Estimate): July 15, 2005

Study Record Updates

• Last Update Posted (Estimate): October 6, 2009
• Last Update Submitted That Met QC Criteria: October 5, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Primary health care; dyspepsia; Proton Pump Inhibitor; discontinuation; Histamine-2-receptor-antagonist
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: 2612-2176; MPU 16-2003; D9612L00060; 02.04; VF 20020212