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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Zollinger-Ellison Syndrome
Both
Zollinger-Ellison Syndrome
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the gastric acid secretory rate at the final study visit.
Principal Investigator
Nexium Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D9612C00025
NCT ID:
NCT00079833
Start Date:
November 2003
Completion Date:
July 2005
Related Keywords:
- Zollinger-Ellison Syndrome
- gastric acid hypersecretory conditions
- Idiopathic Hypersecretion
- Excessive Gastric Acid secretion
- Zollinger-Ellison Syndrome
- Gastrinoma
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Boca Raton, Florida |
| Research Site | Akron, Ohio |
| Research Site | Allentown, Pennsylvania |
