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
About this trial
This is an interventional treatment trial for Zollinger-Ellison Syndrome
Eligibility Criteria
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
NCT ID
NCT00204373
First Posted
September 13, 2005
Last Updated
October 23, 2012
Sponsor
Charles Mel Wilcox, MD
Collaborators
Takeda Pharmaceuticals North America, Inc.
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
Learn more about this trial
Treatment of Zollinger-Ellison Syndrome With Prevacid
We'll reach out to this number within 24 hrs