Target subject population are male and female subjects requiring low-dose acetylsalicylic acid (75-325 mg daily) who are Helicobacter pylori negative and who are at increased risk of developing gastroduodenal ulcers. MedDRA version: 8.1 Level: LLT Classification code 10017886 Term: Gastroduodenal ulcer
Conditions
Interventions
Product Name: Esomeprazole capsules 20 mg
Pharmaceutical Form: Capsule, hard
CAS Number: 217087097
Other descriptive name: ESOMEPRAZOLE MAGNESIUM
Concentration unit: mg milligram(s)
Concentration type
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Physician prescribed or recommended daily intake of low-dose aspirin (75-325 mg daily) that is expected to continue for the duration of the study (daily intake is defined as at least =5 days per week). 3. The subject must fulfill at least one of the following (a-e): a) Aged =65 years. b) Aged =18 years and with a documented history of uncomplicated peptic ulcer(s). c) Aged =60 years and naïve to low-dose aspirin (ie, treatment started within 1 month prior to randomization). d) Aged =60 years with stable coronary artery disease. e) Aged =60 years with complains of upper GI symptoms that, as judged by the investigator, requires an EGD and with the finding of =5 gastric and/or duodenal erosions at the baseline endoscopy. 4. H. pylori negative. (H. pylori test to be performed according to local routines. Eradication treatment completed at least 4 weeks prior to randomization is allowed.). 5. Able to read and write. 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: 1. Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline EGD or within the last year as known by the investigator, or severe esophagitis within the last year as known by the subject (for definition, see Section 4.6.1.1). 2. Peptic ulcer(s) at baseline EGD. 3. History of peptic ulcer complications such as clinically significant bleeding and/or perforation. 4. Any previous surgery of the stomach and/or the duodenum (except for laparoscopic fundoplication). 5. Any of the following vascular diseases: - Unstable hypertension - History of Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG) within the last 3 months - Clinically relevant valvular disease - Serious cardiac failure: New York Heart Association Functional Classification II–IV (NYHA II-IV), Ejection Fraction (EF) <40 % - Cerebrovascular accident within the last 3 months. 6. Any current or historical evidence of the following diseases/conditions: - Malabsorption - Known esophageal stricture - Known Barrett’s esophagus with documented dysplastic changes of any grade - Zollinger-Ellison syndrome - Signs and symptoms of gastric outlet obstruction (eg, abdominal distension or multiple episodes of vomiting) - Pancreatitis - Unstable diabetes mellitus (as judged by the investigator). Stable diabetes controlled by diet, oral agents or insulin is acceptable - Atrophic gastritis - Short bowel syndrome. 7. Evidence of any malignant disease within the last 5 years, except minor superficial skin disease. 8. Continuous treatment with a NSAID including a cyclooxygenase-2 (COX-2)- selective NSAID during the last 2 months prior to randomization. During this period occasional use up to 1 day/per week is allowed. 9. Ongoing anticoagulant therapy, such as warfarin or other vitamin K antagonists. Antiplatelets such as clopidogrel are allowed. 10. Need for concomitant therapy with medication that could interact with esomeprazole, ie, phenytoin, ketoconazole, itraconazole, voriconazole, cisapride, atanzanavir, ritonavir. 11. Known or suspected intolerance or hypersensitivity to esomeprazole or other PPIs or aspirin. 12. Any use of a PPI or prostaglandin analogue within 14 days prior to the baseline EGD and between baseline EGD and randomization, or daily use of a histamine H2-receptor antagonist during the last 14 days prior to the baseline EGD (occasional use of H2-receptor antagonist less than daily is permitted during this period). 13. Need for continuous concurrent therapy with: - Prostaglandin analogues - Sucralfate. 14. Any condition that, in the opinion of the investigator, may either put the subject at risk or influence the result of the study (eg, cardiogenic shock or severe haemodynamic instability, risk for non-compliance, risk for being lost to follow-up), as judged by the investigator. 15. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. 16. Alcohol and/or drug abuse or any other condition associated with poor compliance, as judged by the investigator. 17. Use of any other investigational compound or participation in another clinical study within the last 30 days prior to randomization. 18. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study site). 19. Previous enrolment or randomization in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the effect of esomeprazole 20 and 40 mg once daily (od) versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid (ASA).;Secondary Objective: Compare the effect of esomeprazole 20 and 40 mg od versus placebo on 1+2. the occurrence of duodenal and gastric ulcers during 26 weeks in subjects on continuous low-dose ASA. 3. subject- reported dyspeptic symptoms at the 26-week visit or the last visit, unless the last visit is the baseline visit, assessed by Reflux Disease Questionnaire (RDQ) in subjects on continuous low-dose ASA. 4. subject- reported gastroesophageal reflux disease (GERD) symptoms (heartburn and regurgitation) at the 26-week visit or the last visit, unless the last visit is the baseline visit, assessed by RDQ in subjects on continuous low-dose ASA. 5. Study the number of gastric and/or duodenal erosions during 26 weeks in subjects on continuous low-dose ASA, by treatment. 6. Assess safety and tolerability of treatment with esomeprazole 20 and 40 mg od during 26 weeks in subjects on continuous low-dose ASA. ;Primary end point(s): Development of a gastric and/or a duodenal ulcer. | — |
Countries
Bulgaria, Czech Republic, Finland, Germany, Portugal
Outcome results
None listed