Risk of Uncomplicated Peptic Ulcer in the General Population

Completed

• Conditions: Peptic Ulcer [Iowa Type (107680.0010)]
• Interventions: Drug: Risk of symptomatic peptic ulcer

• Registration Number: NCT01888588
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Risk of uncomplicated peptic ulcer in the general population

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-18
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-28
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Risk of symptomatic peptic ulcer	Control group without symptomatic peptic ulcer (UPU).
Cases	Risk of symptomatic peptic ulcer	Patients with symptomatic peptic ulcer (UPU)

Primary Outcome Measures

Name	Time	Method
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)	From Januar 1 1997 till December 31 2005, an expected average of 4 years.	Relative risk (ratio) of UPU associated with current use of the different types of drugs versus non-use.
Management of aspirin after uncomplicated peptic ulcer (UPU).	From January 1, 1997 till december 31, 2005, an average of 4 years

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain