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

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.
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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. |
- 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
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with Zollinger-Ellison syndrome
Exclusion Criteria:
- Pregnant or lactating females

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
Principal Investigator: | C. Mel Wilcox, M.D. | University of Alabama at Birmingham |
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 |
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 |
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 |