Risk of Uncomplicated Peptic Ulcer in the General Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01888588

Enrollment

4000

Registered

2013-06-28

Start date

2012-09-30

Completion date

2013-05-31

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer [Iowa Type (107680.0010)]

Keywords

Uncomplicated peptic ulcer, Low dose aspirin (ASA), Acid-suppressing drugs, Epidemiology

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

Interventions

DRUGRisk of symptomatic peptic ulcer

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 84 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026