Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
This study has been completed.
Information provided by:
First received: March 16, 2004
Last updated: November 18, 2010
Last verified: November 2010
This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.
Drug: Esomeprazole magnesium (Nexium)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Zollinger-Ellison Syndrome Pancreatic CancerU.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
|Study Start Date:||November 2003|
|Study Completion Date:||July 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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|
Sponsors and Collaborators
|Study Director:||Nexium Medical Science Director, MD||AstraZeneca|