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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
Not Enrolling
Both
Zollinger-Ellison Syndrome

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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 SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania