Zollinger-Ellison Syndrome
Conditions
Keywords
gastric acid hypersecretory conditions, Idiopathic Hypersecretion, Excessive Gastric Acid secretion
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France, United States
Outcome results
None listed