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
What is being tested
Data Collection
Who is being recruted
Digestive System Diseases+9
+ Digestive System Neoplasms
+ Duodenal Diseases
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2003
Summary
Principal SponsorAstraZeneca
Last updated: January 27, 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
Principal SponsorAstraZeneca
Last updated: January 27, 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
Digestive System DiseasesDigestive System NeoplasmsDuodenal DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesNeoplasmsParaneoplastic Endocrine SyndromesParaneoplastic SyndromesPeptic UlcerStomach DiseasesZollinger-Ellison Syndrome
Criteria
2 inclusion criteria required to participate
Males or females at least 18 years of age.
Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion
3 exclusion criteria prevent from participating
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
Suspended
Research Site
Gainesville, United StatesSuspended
Research Site
Columbus, United StatesSuspended
Research Site
King of Prussia, United StatesCompleted8 Study Centers