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OpenTrials
Completed

NCT Number: 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

Completed

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Key information

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, Spain

About this study

Risk of uncomplicated peptic ulcer in the general population

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Risk of symptomatic peptic ulcer

Drug

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

Primary outcomes

  1. 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.

    Relative risk (ratio) of UPU associated with current use of the different types of drugs versus non-use.

  2. Management of aspirin after uncomplicated peptic ulcer (UPU).

    Time frame: From January 1, 1997 till december 31, 2005, an average of 4 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2013
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.