Treatment of Zollinger-Ellison Syndrome With Prevacid

Multiple Endocrine Neoplasia Clinical Trial

Official title:

Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204373
• Other study ID #: F030107005
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 23, 2012
• Start date: March 2003
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

• Pregnant or lactating females

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Gastrinoma
• Multiple Endocrine Neoplasia
• Zollinger-Ellison Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charles Mel Wilcox, MD	Takeda Pharmaceuticals North America, Inc.

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 240 months from study enrollment	No
Secondary	The Median Survival From the Time of Diagnosis.	The median survival from the time of diagnosis	survival or up to 240 months	No