Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
Primary Purpose
Dyspepsia, Gastroesophageal Refluxdisease, Ulcer
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Protonpumpinhibitors, withdrawal, longterm treatment, dyspepsia, functional dyspepsia, gastrooesophageal reflux, upper endoscopy
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
Sites / Locations
- Department of gastroenterology, Glostrup University HospitalRecruiting
Outcomes
Primary Outcome Measures
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Secondary Outcome Measures
Fraction of patients who are willing to withdraw treatment with PPI
Fraction of patients who experience symptoms after withdrawal of treatment.
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
Length of time from withdrawal till symptoms arise
Correlation between levels of gastrin and CgA and time till symptoms arise
Investigators and patients ability to distinguish between active and placebo treatment
Full Information
NCT ID
NCT00363701
First Posted
August 14, 2006
Last Updated
August 14, 2006
Sponsor
Glostrup University Hospital, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00363701
Brief Title
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
Official Title
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Glostrup University Hospital, Copenhagen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Gastroesophageal Refluxdisease, Ulcer
Keywords
Protonpumpinhibitors, withdrawal, longterm treatment, dyspepsia, functional dyspepsia, gastrooesophageal reflux, upper endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Primary Outcome Measure Information:
Title
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Secondary Outcome Measure Information:
Title
Fraction of patients who are willing to withdraw treatment with PPI
Title
Fraction of patients who experience symptoms after withdrawal of treatment.
Title
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
Title
Length of time from withdrawal till symptoms arise
Title
Correlation between levels of gastrin and CgA and time till symptoms arise
Title
Investigators and patients ability to distinguish between active and placebo treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Reimer, MD
Phone
+45 43 23 27 79
Email
chrrei01@glostruphosp.kbhamt.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bytzer, ass. professor, ph.d
Organizational Affiliation
Glostrup University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of gastroenterology, Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Reimer, MD
Phone
43 23 27 79
Email
chrrei01@glostruphosp.kbhamt.dk
12. IPD Sharing Statement
Learn more about this trial
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
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