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

NCT ID: NCT00079833

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-07-31

Brief Summary

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This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

Detailed Description

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Conditions

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Zollinger-Ellison Syndrome

Keywords

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gastric acid hypersecretory conditions Idiopathic Hypersecretion Excessive Gastric Acid secretion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole magnesium (Nexium)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Nexium Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Los Angeles, California, United States

Site Status

Research Site

Gainesville, Florida, United States

Site Status

Research Site

Columbus, Ohio, United States

Site Status

Research Site

King of Prussia, Pennsylvania, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Clichy, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Saint-Germain-en-Laye, , France

Site Status

Countries

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United States France

Other Identifiers

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D9612C00025

Identifier Type: -

Identifier Source: org_study_id