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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01888588
Other study ID # D5040N00006
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated July 14, 2014
Start date September 2012
Est. completion date May 2013

Study information

Verified date July 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Oversight Authority: Not applicable
Study type Observational

Clinical Trial 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


Description:

Risk of uncomplicated peptic ulcer in the general population


Recruitment information / eligibility

Status Completed
Enrollment 4000
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 84 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
Risk of symptomatic peptic ulcer
Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use

Locations

Country Name City State
Spain Research Site Madrid

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

References & Publications (1)

González-Pérez A, Sáez ME, Johansson S, Nagy P, García Rodríguez LA. Risk factors associated with uncomplicated peptic ulcer and changes in medication use after diagnosis. PLoS One. 2014 Jul 8;9(7):e101768. doi: 10.1371/journal.pone.0101768. eCollection 2014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Relative risk (ratio) of UPU associated with current use of the different types of drugs versus non-use. From Januar 1 1997 till December 31 2005, an expected average of 4 years. No
Primary Management of aspirin after uncomplicated peptic ulcer (UPU). From January 1, 1997 till december 31, 2005, an average of 4 years No