- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888588
Risk of Uncomplicated Peptic Ulcer in the General Population
The analyses are conducted in a previous population-based cohort study using The Health Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses are:
To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the general population To estimate the dose-response and duration-response associated with use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the general population To investigate the management of low dose ASA/oral antiplatelets after UPU
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Madrid, Spain
- Research Site
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 40-84 years in 1997-2005 ( see study population description)
Exclusion Criteria:
- Patients aged below age 40 and 85 years and above ( see study population description)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases
Patients with symptomatic peptic ulcer (UPU)
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Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use
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Control group
Control group without symptomatic peptic ulcer (UPU).
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Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative risk (ratio) of uncomplicated peptic ulcer (UPU) associated with low dose ASA, other antiinflammatory drugs and other common drugs for chronic diseases(paracetamol, SSRI, tricyclic antidepressants, anticoagulants, acid suppressing drugs)
Time Frame: From Januar 1 1997 till December 31 2005, an expected average of 4 years.
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Relative risk (ratio) of UPU associated with current use of the different types of drugs versus non-use.
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From Januar 1 1997 till December 31 2005, an expected average of 4 years.
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Management of aspirin after uncomplicated peptic ulcer (UPU).
Time Frame: From January 1, 1997 till december 31, 2005, an average of 4 years
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From January 1, 1997 till december 31, 2005, an average of 4 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5040N00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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