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Treatment of Zollinger-Ellison Syndrome With Prevacid

Primary Purpose

Zollinger-Ellison Syndrome, Multiple Endocrine Neoplasia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lansoprazole (Prevacid)
Sponsored by
Charles Mel Wilcox, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zollinger-Ellison Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Zollinger-Ellison syndrome Exclusion Criteria: Pregnant or lactating females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    single group

    Arm Description

    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.

    Outcomes

    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.
    number of participants with control of gastric acid production

    Secondary Outcome Measures

    The Median Survival From the Time of Diagnosis.
    The median survival from the time of diagnosis

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 23, 2012
    Sponsor
    Charles Mel Wilcox, MD
    Collaborators
    Takeda Pharmaceuticals North America, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00204373
    Brief Title
    Treatment of Zollinger-Ellison Syndrome With Prevacid
    Official Title
    Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Charles Mel Wilcox, MD
    Collaborators
    Takeda Pharmaceuticals North America, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Zollinger-Ellison Syndrome, Multiple Endocrine Neoplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    single group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lansoprazole (Prevacid)
    Other Intervention Name(s)
    Lansoprazole is marketed as Prevacid.
    Intervention Description
    Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.
    Primary Outcome Measure Information:
    Title
    Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
    Description
    number of participants with control of gastric acid production
    Time Frame
    up to 240 months from study enrollment
    Secondary Outcome Measure Information:
    Title
    The Median Survival From the Time of Diagnosis.
    Description
    The median survival from the time of diagnosis
    Time Frame
    survival or up to 240 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with Zollinger-Ellison syndrome Exclusion Criteria: Pregnant or lactating females
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    C. Mel Wilcox, M.D.
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15645403
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21193359
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21073392
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19581810
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    18507843
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    17767471
    Citation
    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.
    Results Reference
    derived

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    Treatment of Zollinger-Ellison Syndrome With Prevacid

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