Clinical trial NCT00120315: Proton Pump Inhibitor Treatment Stop
Official title: Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Keywords: dyspepsia
discontinuation
Primary health care
Helicobacter pylori
Proton Pump Inhibitor
Histamine-2-receptor-antagonist
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Research Unit of General Practice, Odense
name: University of Southern Denmark
name: The Danish Medical Research Council
name: Apotekerfonden af 1991
name: AstraZeneca
name: Danish College of General Practitioners
First posted: 2005-07-15
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure of patient perceived symptom control despite treatment with project medication
timeFrame: 12 months
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: GPs and patients satisfaction
timeFrame: 12 months
measure: Helicobacter pylori status
timeFrame: At enrolement
measure: Resource consumption
timeFrame: 12 months
measure: Days without symptoms
timeFrame: 12 months
measure: Use of otc-medication
timeFrame: 12 months
measure: Sick-leave days
timeFrame: 12 months
measure: Number of visits to primary and secondary healthcare system
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Medical Gastroenterology, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Ove B Schaffalitzky de Muckadell, Professor
role: STUDY_DIRECTOR
References:
citation: 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.