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

Dyspepsia Clinical Trial

Official title:

With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00363701
• Other study ID #: 001
• Status: Recruiting
• Phase: Phase 4
• First received: August 14, 2006
• Last updated: August 14, 2006
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2006
• Source: Glostrup University Hospital, Copenhagen
• Contact: Christina Reimer, MD
• Phone: +45 43 23 27 79
• Email: chrrei01[@]glostruphosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: Drug AdministrationDenmark: Data inspection institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Gastroesophageal Refluxdisease
• Ulcer

Intervention

Drug:
• esomeprazole

Locations

Country	Name	City	State
Denmark	Department of gastroenterology, Glostrup University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Secondary	Fraction of patients who are willing to withdraw treatment with PPI
Secondary	Fraction of patients who experience symptoms after withdrawal of treatment.
Secondary	Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
Secondary	Length of time from withdrawal till symptoms arise
Secondary	Correlation between levels of gastrin and CgA and time till symptoms arise
Secondary	Investigators and patients ability to distinguish between active and placebo treatment