Treatment of Zollinger-Ellison Syndrome With Prevacid

Phase 4

Completed

• Conditions: Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia
• Interventions: Drug: Lansoprazole (Prevacid)

• Registration Number: NCT00204373
• Lead Sponsor: Charles Mel Wilcox, MD

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-05-16
• Results First Submitted QC: 2012-09-19
• Status Verified: 2012-10
• Results First Posted: 2012-10-19
• Last Update Submitted: 2012-10-23
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria

• Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group	Lansoprazole (Prevacid)	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.

Primary Outcome Measures

Name	Time	Method
Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.	up to 240 months from study enrollment	number of participants with control of gastric acid production

Secondary Outcome Measures

Name	Time	Method
The Median Survival From the Time of Diagnosis.	survival or up to 240 months	The median survival from the time of diagnosis