Trial record 2 of 46 for:    "Zollinger-Ellison Syndrome"

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00079833
First received: March 16, 2004
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.


Condition Intervention Phase
Zollinger-Ellison Syndrome
Drug: Esomeprazole magnesium (Nexium)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 25
Study Start Date: November 2003
Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079833

Locations
United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Gainesville, Florida, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Pennsylvania
Research Site
King of Prussia, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
France
Research Site
Clichy, France
Research Site
Paris, France
Research Site
Saint Germain en Laye, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nexium Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00079833     History of Changes
Other Study ID Numbers: D9612C00025
Study First Received: March 16, 2004
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
gastric acid hypersecretory conditions
Idiopathic Hypersecretion
Excessive Gastric Acid secretion

Additional relevant MeSH terms:
Zollinger-Ellison Syndrome
Gastrinoma
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Peptic Ulcer
Stomach Diseases
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014