We are looking at the level of aspirin-associated ulcer bleeds. We are investigating the level of H. pylori infection in aspirin users. People who are positive will be offered eradication treatment. MedDRA version: 9.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection MedDRA version: 9.1 Level: LLT Classification code 10064777 Term: Helicoba
Conditions
Interventions
Product Name: products containing Clarithromycin
Product Code: Clarithromycin
Pharmaceutical Form: Tablet
INN or Proposed INN: CLARITHROMYCIN
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Male or female, 45 years of age or older ii. Written informed consent. iii. Taking aspirin (less than or equal to 300 mg daily). NB:Patients who have previously been tested for H. pylori and/or had previous eradication therapy will not be excluded. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Patients currently taking anti-ulcer therapy. (H2-receptor antagonists i.e. Cimetidine, Famotidine, Nizatidine or Ranitidine & Proton Pump Inhibitors [PPIs] i.e. Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole or Rabeprazole Sodium). ii. Patients currently taking non-selective non-steroidal anti-inflammatory drugs (NSAIDs). (Acelofenac, Acemetacin, Azapropazone, Dexibuprofen, Dexketoprofen, Diclofenac sodium, Diflunisal, Fenbufen, Fenoprofen, Flurbiprofen, Ibuprofen, Indometacin, Ketoprofen, Mefenamic acid, Meloxicam, Nabumetone, Naproxen, Piroxicam, Sulindac, Tenoxicam, or Tiaprofenic acid). iii. Patients who are terminally ill. iv. Patients who are allergic to any of the eradication treatment drugs. v. Patients who are currently being treated with an antibacterial or have had antibacterial treatment within the last 4 weeks. vi. Patients who have had treatment with a PPI (listed above) within the last 2 weeks. vii. Women who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ; Main Objective: * What is the current prevalence of aspirin (75-300mg daily) usage and of H.pylori infection in the proposed study population? * What is the absolute rate of ulcer bleeding in patients using aspirin 75-300mg daily and what increase does this represent compared to control patients? * What is the preference for central versus local enrolment clinics? * What percentage of GPs/patients would be willing to take part in a randomised trial? ; Primary end point(s): Rate of ulcer bleeding in patients using aspirin. Rate of aspirin use. Level of H. pylori infection and subsequent eradication rates. Level of interest from GPs and patients for a randomised study and their preferred enrolment site. | — |
Countries
United Kingdom
Outcome results
None listed