Proton Pump Inhibitor Treatment Stop

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120315
• Other study ID #: 2612-2176
• Secondary ID: MPU 16-2003D9612
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2005
• Last updated: October 5, 2009
• Start date: December 2003
• Est. completion date: March 2007

Study information

• Verified date: October 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Medical Gastroenterology, Odense University Hospital	Odense

Sponsors (7)

Lead Sponsor	Collaborator
Odense University Hospital	Apotekerfonden af 1991, AstraZeneca, Danish College of General Practitioners, Research Unit of General Practice, Odense, The Danish Medical Research Council, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of patient perceived symptom control despite treatment with project medication		12 months	No
Secondary	Gastrointestinal symptoms		12 months	No
Secondary	Quality of life		12 months	No
Secondary	GPs and patients satisfaction		12 months	No
Secondary	Helicobacter pylori status		At enrolement	No
Secondary	Resource consumption		12 months	No
Secondary	Days without symptoms		12 months	No
Secondary	Use of otc-medication		12 months	No
Secondary	Sick-leave days		12 months	No
Secondary	Number of visits to primary and secondary healthcare system		12 months	No