Treatment of Zollinger-Ellison Syndrome With Prevacid
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...
Brief Summary
Official Title: “Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Long-term medical(non-surgical)control of gastric acid production
- Time Frame: unknown
Safety Issue?: No
- Time Frame: unknown
Secondary Measures
- Prevention of relapse of symptoms, lesions & complications.
- Time Frame: unknown
Safety Issue?: No
- Time Frame: unknown
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosed with Zollinger-Ellison syndrome
Exclusion Criteria:
- Pregnant or lactating females
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Charles Mel Wilcox, MD Other
Overall Clinical Trial Officials and Contacts
C. Mel Wilcox, M.D. Principal Investigator University of Alabama at Birmingham
Related Publications
Citations Reporting 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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204373
Study ID Number: F030107005
ClinicalTrials.gov Identifier: NCT00204373
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00204373
