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Risk of Uncomplicated Peptic Ulcer in the General Population

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ClinicalTrials.gov Identifier: NCT01888588
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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


Condition or disease Intervention/treatment
Peptic Ulcer [Iowa Type (107680.0010)] Drug: Risk of symptomatic peptic ulcer

Detailed Description:
Risk of uncomplicated peptic ulcer in the general population

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Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Uncomplicated Peptic Ulcer in the General Population
Study Start Date : September 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Group/Cohort Intervention/treatment
Cases
Patients with symptomatic peptic ulcer (UPU)
Drug: Risk of symptomatic peptic ulcer
Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use

Control group
Control group without symptomatic peptic ulcer (UPU).
Drug: Risk of symptomatic peptic ulcer
Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is conducted using The Health Improvement Network database in the UK. Patients aged 40-84 years between January 1997 and December 2005 with a registration status of permanent or deceased, who were enrolled for at least 2 years with a GP and had 1 year of electronic prescription history. Patients with a code for cancer, peptic ulcer (both uncomplicated and complicated), upper GI bleeding, oesophageal varices, Mallory-Weiss disease, alcohol abuse, liver disease, or coagulopathies before beginning date were excluded from the source population. All patients in the study population were followed up until the end of the study period (December 2005), or until they reached the age of 85, died, met any of the exclusion criteria (including receiving a diagnosis of complicated peptic ulcer disease), or received a diagnosis of uncomplicated peptic ulcer disease.Patient records were manually reviewed to validate cases.
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888588


Locations
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Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Luis A Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
Additional Information:
Publications:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01888588    
Other Study ID Numbers: D5040N00006
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by AstraZeneca:
Uncomplicated peptic ulcer
Low dose aspirin (ASA)
Acid-suppressing drugs
Epidemiology
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases