Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome

Zollinger-Ellison Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079833
• Other study ID #: D9612C00025
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2004
• Last updated: November 18, 2010
• Start date: November 2003
• Est. completion date: July 2005

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrinoma
• Syndrome
• Zollinger-Ellison Syndrome

Intervention

Drug:
• Esomeprazole magnesium (Nexium)

Locations

Country	Name	City	State
France	Research Site	Clichy
France	Research Site	Paris
France	Research Site	Saint Germain en Laye
United States	Research Site	Columbus	Ohio
United States	Research Site	Gainesville	Florida
United States	Research Site	King of Prussia	Pennsylvania
United States	Research Site	Los Angeles	California
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the gastric acid secretory rate at the final study visit.
Primary	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	The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
Secondary	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	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.