Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 14, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedAugust 15, 2006
August 1, 2006
August 14, 2006
August 14, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Treatment with PPI in at least 4 months out of the preceding 12.
- Age above 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of gastroenterology, Glostrup University Hospital
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Bytzer, ass. professor, ph.d
Glostrup University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 14, 2006
First Posted
August 15, 2006
Study Start
August 1, 2006
Study Completion
February 1, 2008
Last Updated
August 15, 2006
Record last verified: 2006-08