Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

Study Overview
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Brief Summary
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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.

Official Title
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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 Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection

Conditions
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Peptic Ulcer Disease

Intervention / Treatment
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* Drug: Esomeprazole/ASA Fixed Combination
* Drug: Esomeprazole
* Drug: ASA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking male and female subjects, aged 18 years or older with a documented history of uncomplicated peptic ulcer(s), or aged 65 years or older Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 35.0 kg/m2 Exclusion Criteria: Known history of hypersensitivity to esomeprazole (e.g. Nexium®) or related drugs such as omeprazole (e.g. Losec®, Prilosec®), lansoprazole (e.g. Prevacid®, Hp-PAC®), pantoprazole (e.g. Pantoloc®, PANTO® IV), or rabeprazole (e.g. Pariet™), a known hypersensitivity to ASA (e.g. Aspirin®) and/or related drugs such as ibuprofen (e.g. Motrin®, Advil®), indomethacin (e.g. Indocin®), diclofenac (e.g. Voltaren®), naproxen (e.g. Aleve®, Naprosyn®), or ketoprofen (e.g. Rhovail®). Significant history of pulmonary, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, or gastrointestinal disease (with the exception of uncomplicated peptic ulcer), unless deemed NCS by the Principal Investigator or Sub-investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule | Drug: Esomeprazole/ASA Fixed Combination<br>* Capsule, oral, single dose<br>|
| Active Comparator: 2<br>Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole<br>* oral, single dose<br>* Other names: Nexium;Drug: ASA<br>* Tablet, oral, single dose<br>* Other names: Aspirin;|
| Active Comparator: 3<br>Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole<br>* oral, single dose<br>* Other names: Nexium;Drug: ASA<br>* Tablet, oral, single dose<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period |  | pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period |  | pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing | 
| Median 24-hour intragastric pH |  | pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing | 
| Gastrointestinal symptom (Global Overall Symptoms questionnaire) |  | GOS questionnaire will be adminsited on day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, pH measurements