Helicobacter eradication to prevent ulcer bleeding in aspirin users
Conditions
Interventions
Trade Name: Lansoprazole 30mg gastro-resistant capsules
Product Name: Lansoprazole 30mg gastro-resistant capsules
Pharmaceutical Form: Capsule
INN or Proposed INN: Lansoprazole
CAS Number: 103577-45-3
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome is the rate of hospitalisation due to peptic ulcer bleeding in patients who enter the randomised study, adjudicated by a blinded Committee as definite or probable.;Main Objective: The research has three primary objectives: 1. Medical: To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin =325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation. 2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit. 3. Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need for industry support.;Secondary Objective: Secondary objectives include evaluating the effect of H. pylori eradication on the following: - Other causes of GI bleeding (these are predicted not to be affected by H. pylori eradication). - Cardiovascular outcomes (these are also predicted not to be affected by H. pylori eradication). - The incidence of detected uncomplicated ulcers. - Ulcer site (duodenal vs. gastric). - GP-recorded and patient-reported dyspepsia. - The need for a proton pump inhibitor (PPI) prescription or other antiulcer/ dyspepsia medication.;Timepoint(s) of evaluation of this end point: Details of potential endpoints will be extracted on a roughly annual basis (and more frequently as the trial nears completion), until 96 adjudicated endpoints occur. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: These outcomes will be determined from GP records (annual interrogation, and more frequently as the trial nears completion); outcomes ii. – vi. will not be formally adjudicated.;Secondary end point(s): i. Other causes of GI bleeding (adjudicated); these are predicted not to be affected by H. pylori eradication and will act as a specificity control. ii. Cardiovascular outcomes (APTC endpoint, MI and stroke, unadjudicated); these are predicted not to be affected. iii. The incidence of detected uncomplicated ulcers. iv. Ulcer site (Duodenal Ulcer vs. Gastric Ulcer). v. GP-recorded and patient-reported dyspepsia. vi. Need for PPI prescription or other antiulcer/dyspepsia medication. | — |
Countries
United Kingdom
Outcome results
None listed