Clinical Trial: Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 a
Brief Summary: This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome:
- 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
Original Primary Outcome:
Current Secondary Outcome:
- 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.
Original Secondary Outcome:
Information By: AstraZeneca
Dates:
Date Received: March 16, 2004
Date Started: November 2003
Date Completion:
Last Updated: November 18, 2010
Last Verified: November 2010
