Peptic Ulcer [Iowa Type (107680.0010)] Clinical Trial
Official title:
Risk of Uncomplicated Peptic Ulcer in the General Population
| Verified date | July 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Oversight Authority: Not applicable |
| Study type | Observational |
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
| 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) |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
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
| 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 |