Completed

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

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What is being tested

Data Collection

Who is being recruted

Adenocarcinoma+23

+ Carcinoma

+ Digestive System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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

Official TitleA 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 
NCT00079833
Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsDiseaseDuodenal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialParaneoplastic Endocrine SyndromesPancreatic DiseasesPancreatic NeoplasmsParaneoplastic SyndromesPathologic ProcessesPeptic UlcerStomach DiseasesSyndromeZollinger-Ellison SyndromeGastrinomaCarcinoma, Islet Cell

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Research Site

Los Angeles, United StatesSee the location
Suspended

Research Site

Gainesville, United States
Suspended

Research Site

Columbus, United States
Suspended

Research Site

King of Prussia, United States
Completed8 Study Centers