Helicobacter eradication to prevent ulcer bleeding in aspirin users

• Conditions: Helicobacter eradication to prevent ulcer bleeding in aspirin users; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-003425-96-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

1. Males and females = 60 years of age at the date of screening.
2. Subjects who are taking aspirin =325mg daily and who have had 4 or more 28-day prescriptions in the last year.
3. Subjects who are concurrently using other anti-platelet agents are allowed to enter the study.
4. Subjects who are willing and able to undergo a breath test for H. pylori, including fasting for 6 hours, and whose result is unequivocally positive (results of breath test will be determined post-screening).
5. Subjects who are willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators.
6. Subjects who are willing to be contacted and interviewed by trial investigators, should the need arise for adverse event assessment, etc.
7. Subjects must be able to communicate well with the investigator or designee, to understand and comply with the requirements of the study and to understand and sign the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35000

Exclusion Criteria

1. Subjects who are currently taking anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors.
2. Subjects who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs).
3. Subjects who have a known intolerance or allergy to H. pylori eradication treatment.
4. Subjects who are taking drugs that have a clinically significant interaction with H. pylori eradication treatment (see Appendix 3 of protocol).
5. Subjects who are terminally ill or suffer from a life-threatening co-morbidity.
6. Subjects whose behaviour or lifestyle would render them less likely to comply with study medication (eg. alcoholism, substance abuse, debilitating psychiatric conditions or inability to provide informed consent).
7. Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the previous three months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified