Risk of Uncomplicated Peptic Ulcer in the General Population

NCT ID: NCT01888588

Last Updated: 2014-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Risk of uncomplicated peptic ulcer in the general population

Conditions

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Peptic Ulcer [Iowa Type (107680.0010)]

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

Patients with symptomatic peptic ulcer (UPU)

Risk of symptomatic peptic ulcer

Intervention Type DRUG

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

Control group

Control group without symptomatic peptic ulcer (UPU).

Risk of symptomatic peptic ulcer

Intervention Type DRUG

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

Interventions

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Risk of symptomatic peptic ulcer

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis A Garcia Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )

Locations

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Research Site

Madrid, , Spain

Site Status

Countries

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Spain

References

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Gonzalez-Perez A, Saez ME, Johansson S, Nagy P, Garcia Rodriguez 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.

Reference Type BACKGROUND
PMID: 25003908 (View on PubMed)

Other Identifiers

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D5040N00006

Identifier Type: -

Identifier Source: org_study_id

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