Treatment of Zollinger-Ellison Syndrome With Prevacid

This study has been completed.

Sponsor:

Collaborator:

Takeda Pharmaceuticals North America, Inc.

Information provided by (Responsible Party):

Charles Mel Wilcox, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00204373

First received: September 13, 2005

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

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 4


Study Type:	Interventional
Study Design:	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

Drug Information available for: Lansoprazole Dexlansoprazole

Genetic and Rare Diseases Information Center resources: Zollinger-Ellison Syndrome

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 Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment. [ Time Frame: up to 240 months from study enrollment ] [ Designated as safety issue: No ]
number of participants with control of gastric acid production

Secondary Outcome Measures:

The Median Survival From the Time of Diagnosis. [ Time Frame: survival or up to 240 months ] [ Designated as safety issue: No ]
The median survival from the time of diagnosis


Enrollment:	72
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 (Adult, Senior)
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

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: 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.

Wilcox CM, Seay T, Arcury JT, Mohnen J, Hirschowitz BI. Zollinger-Ellison syndrome: presentation, response to therapy, and outcome. Dig Liver Dis. 2011 Jun;43(6):439-43. doi: 10.1016/j.dld.2010.11.007. Epub 2010 Dec 30.

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. doi: 10.3109/00365521.2010.536255. 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. doi: 10.1097/MCG.0b013e3181a59aa5.

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. doi: 10.1186/1471-230X-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
Results First Received:	May 16, 2012
Last Updated:	October 23, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Syndrome Multiple Endocrine Neoplasia Endocrine Gland Neoplasms Zollinger-Ellison Syndrome Gastrinoma Disease Pathologic Processes Neoplasms by Site Neoplasms Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Endocrine System Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes	Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases Carcinoma, Islet Cell Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pancreatic Neoplasms Pancreatic Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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