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

Sponsor:	Charles Mel Wilcox, MD
Collaborator:	Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):	Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00204373

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors

Resource links provided by NLM:

Genetics Home Reference related topics: multiple endocrine neoplasia Help Me Understand Genetics

MedlinePlus related topics: Cancer

Drug Information available for: Lansoprazole

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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

Enrollment:	65
Study Start Date:	March 2003
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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. Other Name: Lansoprazole is marketed as Prevacid.

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

Sponsors and Collaborators

Charles Mel Wilcox, MD

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

C. Mel Wilcox, M.D.

University of Alabama at Birmingham

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilcox CM, Seay T, Arcury J, Hirschowitz BI. Presentation, response to lansoprazole therapy, and outcome of Zollinger-Ellison syndrome-like gastric acid hypersecretors. Scand J Gastroenterol. 2011 Mar;46(3):277-80. Epub 2010 Nov 15.

Hirschowitz BI, Fineberg N, Wilcox CM, Mohnen J, Worthington J. Costs and risks in the management of patients with gastric acid hypersecretion. J Clin Gastroenterol. 2010 Jan;44(1):28-33.

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:	Charles Mel Wilcox, MD, Prinicle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00204373 History of Changes
Other Study ID Numbers:	F030107005
Study First Received:	September 13, 2005
Last Updated:	December 5, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Zollinger-Ellison Syndrome
Gastrinoma
Neoplasms by Site
Endocrine System Diseases
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
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
Pancreatic Diseases
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012