Treatment of Zollinger-Ellison Syndrome
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Zollinger Ellison Syndrome
Phase: N/A
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
In patients with Zollinger-Ellison Syndrome the level of gastric acid is elevated. This
increased level of gastric acid is what causes the symptoms of the disease. Certain types of
medication can control the secretion of gastric acid. In this study there are details on how
drugs known as antihistamines (H2 receptor antagonists) can control the levels of gastric
acid secretion.
The study describes; which patients are candidates for this research, what to do prior to
initiating treatment, and the appropriate dose of antihistamine to be given.
Initial doses of the medication will be given intravenously (injected through a vein) and
later doses will be administered orally (by mouth).
By following the procedure, researchers will be able to determine if there is a more
effective route of drug administration, as well as the effectiveness of antihistamines in
patients treated surgically for Zollinger-Ellison pancreatic tumors with mildly elevated
gastric acid levels.
Clinical Details
Official title: Medical Therapy of Zollinger-Ellison Syndrome
Study design: N/A
Detailed description:
This protocol describes the use of histamine H2-receptor antagonists to control gastric acid
hypersecretion in patients with Zollinger-Ellison syndrome. It details which patients will
be considered for treatment with these agents, the pretreatment procedures and the procedures
to be followed in establishing the proper intravenous dose of histamine H2-receptor
antagonist. It also details the procedure to be used to establish a safe and effective oral
long-term maintenance dose of either cimetidine, ranitidine, nizatidine, or famotidine. By
following these procedures it will be possible to evaluate the effectiveness of intravenous
histamine H2 therapy if it is determined this is important for antisecretory control during
periods when patients cannot take oral gastric antisecretory agents. It will also be
possible to evaluate the effectiveness of histamine H2-receptor in patients with
Zollinger-Ellison syndrome after successful gastrinoma resection who continue to have mild
gastric hypersecretion.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA:
Basal gastric acid secretion of greater than 15 mEq/hr (normal less than 10) or greater
than 5 mEq/hr if they have had a previous gastric resection, a fasting plasma concentration
of immunoreactive gastrin of greater than 100 pg/ml (normal less than 100), a positive
secretin provocative tests or histological diagnosis of gastrinoma.
Locations and Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States
Additional Information
Related publications: McCarthy DM, Olinger EJ, May RJ, Long BW, Gardner JD. H2-Histamine receptor blocking agents in the Zollinger-Ellison syndrome. Experience in seven cases and implications for long-term therapy. Ann Intern Med. 1977 Dec;87(6):668-75.
Starting date: January 1989
Ending date: December 2007
Last updated: December 11, 2007
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