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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule |
|
| 2 | Active Comparator | Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg |
|
| 3 | Active Comparator | Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole/ASA Fixed Combination | Drug | Capsule, oral, single dose |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TJorgen Nasdal, MD, PhD | AstraZeneca R&D | Study Director |
| Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P. | Biovail Contract Research (BCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scarborough Village | Ontario | Canada |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole |
| Drug |
oral, single dose |
|
|
| ASA | Drug | Tablet, oral, single dose |
|
|
| Gastrointestinal symptom (Global Overall Symptoms questionnaire) | GOS questionnaire will be adminsited on day 5 |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |