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.