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| ID | Type | Description | Link |
|---|---|---|---|
| D9612L00057 | Other Identifier | AZ |
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This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nexium 40mg |
|
| 2 | Experimental | Nexium 40mg + aspirin |
|
| 3 | Experimental | Nexium 40mg + Rofecoxib 25 mg |
|
| 4 | Active Comparator | Rofecoxib 25mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 40mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment | Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest. | Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Fernstrom | Nexium Global Product Director, AstraZeneca | Study Director |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D001241 | Aspirin |
| C116926 | rofecoxib |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Aspirin | Drug |
|
| Rofecoxib | Drug | 25mg once daily |
|
| D004066 |
| Digestive System 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 |