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Treatment of Zollinger-Ellison Syndrome With Prevacid

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Disease Information

Descriptive Information
Brief Title † Treatment of Zollinger-Ellison Syndrome With Prevacid
Official Title † Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors
Brief Summary The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
Detailed Description The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.
Study Phase Phase 4
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
Secondary Outcome Measure † The Median Survival From the Time of Diagnosis.
Condition † Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia
Intervention † DrugLansoprazole (Prevacid)
Study Arms / Comparison Groups single group This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 72
Start Date † March 2003
Completion Date December 2010
Primary Completion Date December 2010
Eligibility Criteria † Inclusion Criteria: - Diagnosed with Zollinger-Ellison syndrome Exclusion Criteria: - Pregnant or lactating females
Gender Both
Ages 19 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT00204373
Organization ID F030107005
Secondary IDs ††
Responsible Party Sponsor-Investigator
Study Sponsor † Charles Mel Wilcox, MD
Collaborators †† Takeda Pharmaceuticals North America, Inc.
Investigators † Principal Investigator: C. Mel Wilcox, M.D., University of Alabama at Birmingham
Information Provided By
Verification Date October 2012
First Received Date † September 13, 2005
Last Updated Date October 23, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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