The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid
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|ClinicalTrials.gov Identifier: NCT00001191|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
|First Submitted Date ICMJE||November 3, 1999|
|First Posted Date ICMJE||November 4, 1999|
|Last Update Posted Date||July 2, 2017|
|Study Start Date ICMJE||February 3, 1983|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001191 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid|
|Official Title ICMJE||The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid|
Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous control of their gastric acid secretion. If gastric acid levels are permitted to rise higher than normal, patients may develop severe ulcers and other complications.
This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to decrease the amount of gastric acid secreted.
Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests. The proper dose of Omeprazole will then be determined in each patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level.
Every year patients participating in this study will undergo a physical examination and history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome. Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy.
The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion.
Patients with Zollinger-Ellison syndrome require continuous control of their gastric acid secretion or else severe complications of peptic ulcer disease will occur. This study investigates the long-term efficacy of the oral gastric acid antisecretory drug, Omeprazole, which functions as a H+ - K+ ATPase inhibitor. Long-term safety will also be investigated. Also investigated is the ability of the parenteral H+-K+ ATPase inhibitor, pantoprazole to control acid secretion short-term, when oral Omeprazole cannot be used.
In this study the proper maintenance dose of oral Omeprazole will be determined in each patient by determining the minimal dose of drug that reduces acid secretion to safe levels. Patients will be examined at least annually for evidence of continued efficacy and safety. Efficacy will be assessed by clinical history to assess control of symptoms due to gastric acid hypersecretion, measurements of gastric acid secretion while on Omeprazole to determine continued effectiveness of the drug and upper gastrointestinal endoscopy to assess changes in the gastrointestinal mucosa. Safety will be determined by assessing clinical and laboratory parameters such as changes in hematologic or clinical chemistry parameters. Possible drug induced changes in the gastric mucosa will be assessed by gastric biopsies.
With intravenous pantoprazole the ability of the recommended dose of 80 mg three times a day to control acid secretion will be investigated and if this fails, 80 mg four times a day will be assessed.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms ICMJE||Not Provided|
|Publications *||Richardson CT, Walsh JH. The value of a histamine H2-receptor antagonist in the management of patients with the Zollinger-Ellison syndrome. N Engl J Med. 1976 Jan 15;294(3):133-5.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE
|Study Completion Date ICMJE||December 10, 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects for receiving oral Omeprazole will be patients who have idiopathic gastric acid hypersecretion with basal rates of gastric acid secretion of greater than 15 mEq/hr and patients with Zollinger-Ellison syndrome with basal acid output greater than 10mEq/hr are eligible.
Subjects with gastric acid hypersecretory states who are being treated with various antisecretory drugs under the protocols entitled "Medical Therapy of Zollinger-Ellison Syndrome" (89-DK-0015) are eligible.
Patients must be 18 years of age or older.
Female patients of childbearing age who are attempting to become pregnant, are pregnant, or are unwilling to practice effective birth control will be excluded.
Patients who develop adverse reactions or allergic responses to Omeprazole will be excluded.
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001191|
|Other Study ID Numbers ICMJE||830018
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 10, 2007|
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