Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Aspirin; Esomeprazole

Criteria

Inclusion Criteria:

• Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):

• Aged ≥65 years.

• Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).

• Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).

• Aged ≥60 years and with stable coronary artery disease.

• Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

• Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).

• Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline

• History of peptic ulcer complications such as clinically significant bleeding and/or perforation.