Treatment of Zollinger-Ellison Syndrome With Prevacid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00204373

Recruitment Status : Completed

First Posted : September 20, 2005

Results First Posted : October 19, 2012

Last Update Posted : October 30, 2012

Sponsor:

Collaborator:

Takeda Pharmaceuticals North America, Inc.

Information provided by (Responsible Party):

Charles Mel Wilcox, MD, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia	Drug: Lansoprazole (Prevacid)	Phase 4

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	March 2003
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple endocrine neoplasia

Drug Information available for: Lansoprazole Dexlansoprazole

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

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]
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 ]
The median survival from the time of diagnosis

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

Pregnant or lactating females

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204373

Sponsors and Collaborators

Charles Mel Wilcox, MD

Takeda Pharmaceuticals North America, Inc.

Investigators

Layout table for investigator information

Principal Investigator:	C. Mel 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.

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.

Layout table for additonal information

Responsible Party:	Charles Mel Wilcox, MD, Prinicle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00204373
Other Study ID Numbers:	F030107005
First Posted:	September 20, 2005 Key Record Dates
Results First Posted:	October 19, 2012
Last Update Posted:	October 30, 2012
Last Verified:	October 2012

Additional relevant MeSH terms:

Layout table for MeSH terms

Endocrine Gland Neoplasms Multiple Endocrine Neoplasia Zollinger-Ellison Syndrome Gastrinoma Syndrome Disease Pathologic Processes Neoplasms 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 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

To Top