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Treatment of Zollinger-Ellison Syndrome With Prevacid

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00204373
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Zollinger-Ellison Syndrome
Multiple Endocrine Neoplasia
 Drug: Lansoprazole (Prevacid)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

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. [ Time Frame: up to 240 months from study enrollment ] [ Designated as safety issue: No ]
    number of participants with control of gastric acid production


Secondary Outcome Measures:
  • The Median Survival From the Time of Diagnosis. [ Time Frame: survival or up to 240 months ] [ Designated as safety issue: No ]
    The median survival from the time of diagnosis


Enrollment: 72
Study Start Date: March 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Other Name: Lansoprazole is marketed as Prevacid.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

  • Pregnant or lactating females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204373

Sponsors and Collaborators
Charles Mel Wilcox, MD
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: C. Mel Wilcox, M.D. University of Alabama at Birmingham
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charles Mel Wilcox, MD, Prinicle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00204373     History of Changes
Other Study ID Numbers: F030107005
Study First Received: September 13, 2005
Results First Received: May 16, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Zollinger-Ellison Syndrome
Gastrinoma
Neoplasms by Site
Endocrine System Diseases
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Intestinal Diseases
Peptic Ulcer
Stomach Diseases
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Pancreatic Diseases
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013