Treatment of Zollinger-Ellison Syndrome With Prevacid
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00204373
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: October 2012
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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:
Genetics Home Reference related topics:
multiple endocrine neoplasia
Genetic and Rare Diseases Information Center resources:
Pancreatic Cancer
Zollinger-Ellison Syndrome
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204373
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:
|
Gastrinoma Multiple Endocrine Neoplasia Zollinger-Ellison Syndrome Adenocarcinoma Carcinoma Carcinoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Pancreatic Diseases Pancreatic Neoplasms Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Peptic Ulcer Stomach Diseases Dexlansoprazole Lansoprazole Anti-Ulcer Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015