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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00079833

First received: March 16, 2004

Last updated: November 18, 2010

Last verified: November 2010

History of Changes

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 (Nexium)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Magnesium Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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:	November 2003
Study Completion Date:	July 2005

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
King of Prussia, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
France
Research Site
Clichy, France
Research Site
Paris, France
Research Site
Saint Germain en Laye, France

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Nexium Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00079833 History of Changes
Other Study ID Numbers:	D9612C00025
Study First Received:	March 16, 2004
Last Updated:	November 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

gastric acid hypersecretory conditions
Idiopathic Hypersecretion
Excessive Gastric Acid secretion

Additional relevant MeSH terms:

Zollinger-Ellison Syndrome
Gastrinoma
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Peptic Ulcer
Stomach Diseases
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013

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