Risk of Uncomplicated Peptic Ulcer in the General Population

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Risk of Uncomplicated Peptic Ulcer in the General Population

ClinicalTrials.gov ID

NCT01888588

Acronym / sponsor ID

D5040N00006

Conditions

Peptic Ulcer [Iowa Type (107680.0010)]

Keywords

Uncomplicated peptic ulcer, Low dose aspirin (ASA), Acid-suppressing drugs, Epidemiology

Study type

Observational

Recruitment status

Completed

Enrolment

4,000 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

Sep 2012

Primary completion

May 2013 (actual)

Study completion

May 2013 (actual)

First posted

28 Jun 2013 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

2

Who may qualify

Ages

40 to 84 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
• Background: PubMed 25003908Gonzalez-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.
• D5040N00006.pdfLink provided by the sponsor.
• D5040N00006\_Redacted\_ProtocolLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.