Treatment of Zollinger-Ellison Syndrome With Prevacid
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| ClinicalTrials.gov Identifier: NCT00204373 |
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Recruitment Status
:
Completed
First Posted
: September 20, 2005
Results First Posted
: October 19, 2012
Last Update Posted
: October 30, 2012
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Sponsor:
Charles Mel Wilcox, MD
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 72 participants |
| 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
Genetics Home Reference related topics:
Multiple endocrine neoplasia
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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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 ]number of participants with control of gastric acid production
Secondary Outcome Measures
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- The Median Survival From the Time of Diagnosis. [ Time Frame: survival or up to 240 months ]The median survival from the time of diagnosis
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| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with Zollinger-Ellison syndrome
Exclusion Criteria:
- Pregnant or lactating females
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
| Principal Investigator: | C. Mel Wilcox, M.D. | University of Alabama at Birmingham |
Publications of Results:
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 |
| 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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Syndrome Multiple Endocrine Neoplasia Endocrine Gland Neoplasms Zollinger-Ellison Syndrome Gastrinoma Disease Pathologic Processes Neoplasms by Site Neoplasms Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Endocrine System Diseases 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 |