Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363701
Status:
UNKNOWN
Last Update Posted:
2006-08-15
First Post:
2006-08-14
Brief Title:
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
Sponsor:
Glostrup University Hospital Copenhagen
Organization:
Glostrup University Hospital Copenhagen
Study Overview
Official Title:
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 treatmentIf the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo
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 treatmentIf the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None