Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Phase 3
Completed
- Conditions
- Zollinger-Ellison Syndrome
- Registration Number
- NCT00079833
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
🇫🇷Saint Germain en Laye, France