Clinical Trial: Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With F
Brief Summary: 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.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: November 17, 2009
Date Started: November 2009
Date Completion:
Last Updated: January 13, 2012
Last Verified: January 2012
