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

Purpose

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	Intervention	Phase
Zollinger-Ellison Syndrome	Drug: Esomeprazole magnesium	Phase III

Drug Information available for:

Magnesium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment:	25
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079833

Locations


United States, California
	Research Site
	Los Angeles, California, United States

United States, Florida
	Research Site
	Gainesville, Florida, United States

United States, Ohio
	Research Site
	Columbus, Ohio, United States

United States, Pennsylvania
	Research Site
	Philadelphia, Pennsylvania, United States
	Research Site
	King Of Prussia, Pennsylvania, United States

France
	Research Site
	Paris, France
	Research Site
	Saint-Germain-en-Laye, France
	Research Site
	Clichy, France

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Nexium Medical Science Director, MD	AstraZeneca

More Information

Study ID Numbers:	D9612C00025
First Received:	March 16, 2004
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00079833
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

gastric acid hypersecretory conditions

Idiopathic Hypersecretion

Excessive Gastric Acid secretion

Study placed in the following topic categories:

Stomach Diseases

Digestive System Diseases

Digestive System Neoplasms

Paraneoplastic Syndromes

Gastrointestinal Diseases

Ulcer

Zollinger-Ellison Syndrome

Zollinger-Ellison syndrome

Omeprazole

Gastrointestinal Neoplasms

Intestinal Diseases

Peptic Ulcer

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Syndrome

Anti-Ulcer Agents

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

Paraneoplastic Endocrine Syndromes

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00079833