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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00079833 |
Purpose
This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.
| Condition | Intervention | Phase |
|---|---|---|
|
Zollinger-Ellison Syndrome |
Drug: Esomeprazole magnesium |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months |
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2003 |
| Study Completion Date: | July 2005 |
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| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| United States, Florida | |
| Research Site | |
| Gainesville, Florida, United States | |
| United States, Ohio | |
| Research Site | |
| Columbus, Ohio, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| Research Site | |
| King of Prussia, Pennsylvania, United States | |
| France | |
| Research Site | |
| Paris, France | |
| Research Site | |
| Saint Germain en Laye, France | |
| Research Site | |
| Clichy, France | |
| Study Director: | Nexium Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | D9612C00025 |
| Study First Received: | March 16, 2004 |
| Last Updated: | March 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079833 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
gastric acid hypersecretory conditions Idiopathic Hypersecretion Excessive Gastric Acid secretion |
|
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Pancreatic Neoplasms Omeprazole Paraneoplastic Endocrine Syndromes Pathologic Processes Stomach Diseases Neoplasms by Site Therapeutic Uses Zollinger-Ellison Syndrome Syndrome Anti-Ulcer Agents Peptic Ulcer Endocrine Gland Neoplasms Digestive System Neoplasms |
Disease Neoplasms by Histologic Type Carcinoma, Islet Cell Gastrointestinal Agents Endocrine System Diseases Enzyme Inhibitors Intestinal Diseases Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Paraneoplastic Syndromes Gastrinoma Gastrointestinal Neoplasms Pancreatic Diseases |