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Treatment of Zollinger-Ellison Syndrome With Prevacid

NCT ID: NCT00204373

Last Updated: 2012-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lansoprazole (Prevacid)

Intervention Type DRUG

Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lansoprazole is marketed as Prevacid.

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria

* Pregnant or lactating females
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role collaborator

Charles Mel Wilcox, MD

OTHER

Sponsor Role lead

Responsible Party

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Charles Mel Wilcox, MD

Prinicle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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C. Mel Wilcox, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Countries

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United States

References

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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. doi: 10.1016/s1542-3565(04)00606-8.

Reference Type RESULT
PMID: 15645403 (View on PubMed)

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.

Reference Type RESULT
PMID: 21193359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21073392 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19581810 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18507843 (View on PubMed)

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. doi: 10.1111/j.1365-2036.2007.03439.x.

Reference Type DERIVED
PMID: 17767471 (View on PubMed)

Other Identifiers

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F030107005

Identifier Type: -

Identifier Source: org_study_id