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


Phase 4
19 Years
N/A
Not Enrolling
Both
Zollinger-Ellison Syndrome, Multiple Endocrine Neoplasia

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Trial Information

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


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.


Inclusion Criteria:



- Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

- Pregnant or lactating females

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.

Outcome Description:

number of participants with control of gastric acid production

Outcome Time Frame:

up to 240 months from study enrollment

Safety Issue:

No

Principal Investigator

C. Mel Wilcox, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F030107005

NCT ID:

NCT00204373

Start Date:

March 2003

Completion Date:

December 2010

Related Keywords:

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

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