Back to resultsEsomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Primary Purpose
Zollinger-Ellison Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole magnesium (Nexium)
Sponsored by
About this trial
This is an interventional treatment trial for Zollinger-Ellison Syndrome focused on measuring gastric acid hypersecretory conditions, Idiopathic Hypersecretion, Excessive Gastric Acid secretion
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
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Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00079833
Brief Title
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zollinger-Ellison Syndrome
Keywords
gastric acid hypersecretory conditions, Idiopathic Hypersecretion, Excessive Gastric Acid secretion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole magnesium (Nexium)
Primary Outcome Measure Information:
Title
To assess the gastric acid secretory rate at the final study visit.
Title
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 Measure Information:
Title
The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nexium Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
King of Prussia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Clichy
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Saint Germain en Laye
Country
France
12. IPD Sharing Statement
Learn more about this trial
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
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