Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

NCT ID: NCT00363701

Last Updated: 2006-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-02-29

Brief Summary

The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.

Detailed Description

The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.

In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.

Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.

In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.

We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.

An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.

Conditions

Dyspepsia; Gastroesophageal Refluxdisease; Ulcer

Keywords

Protonpumpinhibitors; withdrawal; longterm treatment; dyspepsia; functional dyspepsia; gastrooesophageal reflux; upper endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

esomeprazole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Treatment with PPI in at least 4 months out of the preceding 12.
• Use of PPI in the preceding 10 out of 30 days before inclusion
• Age above 18 years

Exclusion Criteria

• Erosive Esophagitis
• PPI-treatment as prophylaxis against gastrointestinal bleeding
• PPI-treatment as prophylaxis against ulcers
• PPI-treatment as prophylaxis because of NSAID-treatment
• Pregnant or lactating women
• Previous upper GI surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Principal Investigators

Peter Bytzer, ass. professor, ph.d

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital

Locations

Department of gastroenterology, Glostrup University Hospital

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Christina Reimer, MD

Role: CONTACT

Phone: +45 43 23 27 79

Email: chrrei01@glostruphosp.kbhamt.dk

Facility Contacts

Christina Reimer, MD

Role: primary

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id