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| Sponsored by: |
AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00637988 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Barrett's Esophagus |
Drug: Esomeprazole Drug: Aspirin Drug: Rofecoxib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
| Official Title: | A Multicenter, Open-Label, Four-Way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus |
| Estimated Enrollment: | 32 |
| Study Start Date: | April 2002 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Nexium 40mg
|
Drug: Esomeprazole
40mg twice daily
|
|
2: Experimental
Nexium 40mg + aspirin
|
Drug: Esomeprazole
40mg twice daily
Drug: Aspirin
|
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3: Experimental
Nexium 40mg + Rofecoxib 25 mg
|
Drug: Esomeprazole
40mg twice daily
|
|
4: Active Comparator
Rofecoxib 25mg
|
Drug: Rofecoxib
25mg once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Astra Zeneca ( Tore Lind, MD - Nexium Medical Science Director ) |
| Study ID Numbers: | 316, D9612L00057 |
| Study First Received: | March 11, 2008 |
| Last Updated: | March 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00637988 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Barrett's Esophagus Nexium |
|
Anti-Inflammatory Agents Gastrointestinal Diseases Omeprazole Fibrinolytic Agents Cyclooxygenase 2 Inhibitors Dinoprostone Fibrin Modulating Agents Aspirin Phenylephrine Barrett Esophagus Anti-Inflammatory Agents, Non-Steroidal Analgesics Congenital Abnormalities |
Cyclooxygenase Inhibitors Cardiovascular Agents Oxymetazoline Digestive System Diseases Digestive System Abnormalities Esophageal Disorder Barrett Syndrome Analgesics, Non-Narcotic Rofecoxib Platelet Aggregation Inhibitors Esophageal Diseases Peripheral Nervous System Agents Antirheumatic Agents |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Hematologic Agents Omeprazole Fibrinolytic Agents Cyclooxygenase 2 Inhibitors Fibrin Modulating Agents Aspirin Sensory System Agents Therapeutic Uses Anti-Ulcer Agents Anti-Inflammatory Agents, Non-Steroidal Barrett Esophagus |
Analgesics Cyclooxygenase Inhibitors Gastrointestinal Agents Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Digestive System Diseases Digestive System Abnormalities Analgesics, Non-Narcotic Rofecoxib Platelet Aggregation Inhibitors Peripheral Nervous System Agents Esophageal Diseases Antirheumatic Agents Central Nervous System Agents |