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

Phase 2
18 Years
Not Enrolling
Gastrinoma, Zollinger Ellison Syndrome

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

February 1983

Completion Date:

December 2007

Related Keywords:

  • Gastrinoma
  • Zollinger Ellison Syndrome
  • Zollinger-Ellison Syndrome
  • Gastrinoma
  • Acid Hypersecretion
  • H+-K+ ATPase Inhibitor
  • Gastrinoma
  • Zollinger-Ellison Syndrome



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892