Clinical Trial: Risk of Uncomplicated Peptic Ulcer in the General Population

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Risk of Uncomplicated Peptic Ulcer in the General Population

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 Summary: Risk of uncomplicated peptic ulcer in the general population
Sponsor: AstraZeneca

Current Primary Outcome:

  • 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.
  • Management of aspirin after uncomplicated peptic ulcer (UPU). [ Time Frame: From January 1, 1997 till december 31, 2005, an average of 4 years ]


Original Primary Outcome:

  • Relative risk 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) [ Time Frame: From Januar 1 1997 till December 31 2005, an expected average of 4 years. ]
    Relative risk of UPU associated with the different types of drugs.
  • Effect of gastroprotective drug use on risk of uncomplicated peptic ulcer (UPU). [ Time Frame: From January 1 1997 till December 31, 2005, an average of 4 years ]
  • Management of aspirin after uncomplicated peptic ulcer (UPU). [ Time Frame: From January 1, 1997 till december 31, 2005, an average of 4 years ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: AstraZeneca

Dates:
Date Received: March 18, 2013
Date Started: September 2012
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014