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Treatment of Zollinger-Ellison Syndrome With Prevacid

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ClinicalTrials.gov Identifier: NCT00204373
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : October 19, 2012
Last Update Posted : October 30, 2012
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    number of participants with control of gastric acid production


Secondary Outcome Measures :
  1. The Median Survival From the Time of Diagnosis. [ Time Frame: survival or up to 240 months ]
    The median survival from the time of diagnosis


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

  • Pregnant or lactating females
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204373


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

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

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Responsible Party: Charles Mel Wilcox, MD, Prinicle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00204373    
Other Study ID Numbers: F030107005
First Posted: September 20, 2005    Key Record Dates
Results First Posted: October 19, 2012
Last Update Posted: October 30, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Zollinger-Ellison Syndrome
Gastrinoma
Syndrome
Disease
Pathologic Processes
Neoplasms
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
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Pancreatic Diseases