Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00079833|
Recruitment Status : Completed
First Posted : March 17, 2004
Last Update Posted : November 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Zollinger-Ellison Syndrome||Drug: Esomeprazole magnesium (Nexium)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2003|
|Actual Study Completion Date :||July 2005|
- To assess the gastric acid secretory rate at the final study visit.
- Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery
- The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
- Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.
- The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079833
|United States, California|
|Los Angeles, California, United States|
|United States, Florida|
|Gainesville, Florida, United States|
|United States, Ohio|
|Columbus, Ohio, United States|
|United States, Pennsylvania|
|King of Prussia, Pennsylvania, United States|
|Philadelphia, Pennsylvania, United States|
|Saint Germain en Laye, France|
|Study Director:||Nexium Medical Science Director, MD||AstraZeneca|