Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Zollinger-Ellison Syndrome
Intervention: Esomeprazole magnesium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Males or females at least 18 years of age.
Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion
Exclusion Criteria:
Pregnant or lactating females
History of drug addiction or alcohol abuse within 12 months prior to Screening.
History of intolerance to any proton pump inhibitors or any ingredient in their
formulation.
Locations and Contacts
Research Site, Paris, France
Research Site, Saint-Germain-en-Laye, France
Research Site, Clichy, France
Research Site, Los Angeles, California, United States
Research Site, Gainesville, Florida, United States
Research Site, Columbus, Ohio, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, King Of Prussia, Pennsylvania, United States
Additional Information
Starting date: July 2003
Last updated: October 21, 2005
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