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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00079833

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Zollinger-Ellison Syndrome	Drug: Esomeprazole magnesium (Nexium)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2003

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

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 Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Los Angeles	California	United States
2	Research Site	Gainesville	Florida	United States
3	Research Site	Columbus	Ohio	United States
4	Research Site	King of Prussia	Pennsylvania	United States
5	Research Site	Philadelphia	Pennsylvania	United States
6	Research Site	Clichy		France
7	Research Site	Paris		France
8	Research Site	Saint Germain en Laye		France