Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome

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

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
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.

Overall Status Completed
Start Date 2003-11-01
Completion Date 2005-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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.
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Esomeprazole magnesium (Nexium)

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nexium Medical Science Director, MD Study Director AstraZeneca
Location
Facility:
Research Site | Los Angeles, California, United States
Research Site | Gainesville, Florida, United States
Research Site | Columbus, Ohio, United States
Research Site | King of Prussia, Pennsylvania, United States
Research Site | Philadelphia, Pennsylvania, United States
Research Site | Clichy, France
Research Site | Paris, France
Research Site | Saint Germain en Laye, France
Location Countries

France

United States

Verification Date

2010-11-01

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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