Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
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
1 other identifier
interventional
25
2 countries
8
Brief Summary
This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2003
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 16, 2004
CompletedFirst Posted
Study publicly available on registry
March 17, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedNovember 19, 2010
November 1, 2010
March 16, 2004
November 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Males or females at least 18 years of age.
- Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Los Angeles, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Columbus, Ohio, United States
Research Site
King of Prussia, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Clichy, France
Research Site
Paris, France
Research Site
Saint-Germain-en-Laye, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nexium Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 16, 2004
First Posted
March 17, 2004
Study Start
November 1, 2003
Study Completion
July 1, 2005
Last Updated
November 19, 2010
Record last verified: 2010-11