The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
Research Site
Scarborough Village, Ontario, Canada
Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Median 24-hour intragastric pH
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Gastrointestinal symptom (Global Overall Symptoms questionnaire)
Time frame: GOS questionnaire will be adminsited on day 5
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