A Phase 4 interventional study of esomeprazole and Helicobacter pylori c-13 breath test in Dyspepsia, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-06.
Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment
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.
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.
370 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 171 is above the median of 87 across 303 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Long-term users continue antisecretory medication
Drug: esomeprazole · Procedure: Helicobacter pylori c-13 breath test
Long-term users are treated with placebo
Drug: esomeprazole · Procedure: Helicobacter pylori c-13 breath test
esomeprazole, original Nexium, 40 mg pills Up to once a day
Breath test done at entry to find Helicobacter pylori
Failure of patient perceived symptom control despite treatment with project medication
Time frame: 12 months
Gastrointestinal symptoms
Time frame: 12 months
Quality of life
Time frame: 12 months
GPs and patients satisfaction
Time frame: 12 months
Helicobacter pylori status
Time frame: At enrolement
Resource consumption
Time frame: 12 months
Days without symptoms
Time frame: 12 months
Use of otc-medication
Time frame: 12 months
Sick-leave days
Time frame: 12 months
Number of visits to primary and secondary healthcare system
Time frame: 12 months
The record gives a start of Dec 2003, a primary completion of Mar 2007 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esomeprazole