Treatment of Zollinger-Ellison Syndrome With Prevacid - Full Text View

Purpose

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.

Condition	Intervention	Phase
Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia	Drug: Lansoprazole (Prevacid)	Phase IV

Genetics Home Reference related topics:

multiple endocrine neoplasia

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Long-term medical(non-surgical)control of gastric acid production [ Time Frame: unknown ] [ Designated as safety issue: No ]
Medical control of symptoms [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevention of relapse of symptoms, lesions & complications. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single group: Experimental 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.	Drug: Lansoprazole (Prevacid) Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204373

Contacts


Contact: Toni Seay, M.S.	205-934-7332	tamartin@uab.edu

Locations


United States, Alabama
	University of Alabama	Recruiting
	Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators


Principal Investigator:	C. Mel I Wilcox, M.D.	University of Alabama at Birmingham

More Information

Publications of Results:

Hirschowitz BI, Simmons J, Mohnen J. Clinical outcome using lansoprazole in acid hypersecretors with and without Zollinger-Ellison syndrome: a 13-year prospective study. Clin Gastroenterol Hepatol. 2005 Jan;3(1):39-48.

Publications indexed to this study:

Wilcox CM, Martin T, Phadnis M, Mohnen J, Worthington J, Hirschowitz BI. Absence of gastrointestinal infections in a cohort of patients with Zollinger-Ellison syndrome and other acid hypersecretors receiving long-term acid suppression with lansoprazole. BMC Gastroenterol. 2008 May 28;8:18.

Hirschowitz BI, Worthington J, Mohnen J, Haber M. Chromogranin A in patients with acid hypersecretion and/or hypergastrinaemia. Aliment Pharmacol Ther. 2007 Sep 15;26(6):869-78.

Responsible Party:	University of Alabama at Birmingham Medical Center ( C. Mel Wilcox, M. D. )
Study ID Numbers:	F030107005
First Received:	September 13, 2005
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00204373
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Neoplasms

Gastrointestinal Diseases

Ulcer

Endocrine System Diseases

Intestinal Diseases

Stomach Diseases

Neoplastic Syndromes, Hereditary

Paraneoplastic Syndromes

Digestive System Diseases

Genetic Diseases, Inborn

Zollinger-Ellison Syndrome

Zollinger-Ellison syndrome

Gastrointestinal Neoplasms

Lansoprazole

Endocrinopathy

Multiple Endocrine Neoplasia

Peptic Ulcer

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Anti-Infective Agents

Disease

Molecular Mechanisms of Pharmacological Action

Neoplasms, Multiple Primary

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

Paraneoplastic Endocrine Syndromes

Neoplasms

Neoplasms by Site

Pathologic Processes

Syndrome

Therapeutic Uses

Anti-Ulcer Agents

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00204373