Risk of Uncomplicated Peptic Ulcer in the General Population

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01888588

Collaborator

(none)

4,000

Enrollment

Location

Duration (Months)

503.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer [Iowa Type (107680.0010)]	Drug: Risk of symptomatic peptic ulcer

Detailed Description

Risk of uncomplicated peptic ulcer in the general population

Study Design

Study Type:

Observational

Actual Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Risk of Uncomplicated Peptic Ulcer in the General Population

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Cases Patients with symptomatic peptic ulcer (UPU)	Drug: Risk of symptomatic peptic ulcer Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use
Control group Control group without symptomatic peptic ulcer (UPU).	Drug: Risk of symptomatic peptic ulcer Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use

Arm

Intervention/Treatment

Cases

Patients with symptomatic peptic ulcer (UPU)

Drug: Risk of symptomatic peptic ulcer

Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use

Control group

Control group without symptomatic peptic ulcer (UPU).

Drug: Risk of symptomatic peptic ulcer

Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Madrid		Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Luis A Garcia Rodriguez, MD, CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )