For Investigators

man holding hands on stomach

Trial recruitment

How many patients are involved?

From our pilot study we expect 40,000 patients to respond (from 120,000 invited) and that 10,000 will be H. pylori positive; 5000 of these will be randomised to eradication treatment and 5000 to matching placebo.

Who can enter?

Inclusion criteria

  • Males and females ≥ 60 years of age at the date of screening.
  • Subjects who are taking aspirin ≤325mg daily and who have had 4 or more 28-day prescriptions in the last year.
  • Subjects who are concurrently using other anti-platelet agents are allowed to enter the study.

Exclusion criteria

  • Subjects who are currently taking anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors.
  • Subjects who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs).
  • Subjects who have a known intolerance or allergy to H. pylori eradication treatment.
  • Subjects who are taking drugs with a clinically significant interaction with H. pylori eradication treatment.
  • Subjects who are terminally ill or suffer from a life-threatening co-morbidity.
  • 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).
  • Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the previous three months.
  • Protocol [.pdf 576KB]