Protocol Number: 83-DK-0018

Title:

The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients with Hypersecretion of Gastric Acid

Number:

83-DK-0018

Summary:

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.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Special Instructions: Currently Not Provided

Keywords:

Zollinger-Ellison Syndrome

Gastrinoma

Acid Hypersecretion

H+-K+ ATPase Inhibitor

Recruitment Keywords:

None

Conditions:

Gastrinoma

Zollinger Ellison Syndrome

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

H2-Histamine receptor blocking agents in the Zollinger-Ellison syndrome Experience in seven cases and implications for long-term therapy

Report on the United States experience with cimetidine in Zollinger-Ellision syndrome and other hypersecretory states

The value of a histamine H2-receptor antagonist in the management of patients with the Zollinger-Ellison syndrome

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