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Treatment of Zollinger-Ellison Syndrome
This study has been completed.
Study NCT00001241   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: March 5, 2008   History of Changes

November 3, 1999
March 5, 2008
January 1989
 
 
 
Complete list of historical versions of study NCT00001241 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Zollinger-Ellison Syndrome
Medical Therapy of Zollinger-Ellison Syndrome

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.

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.

 
Observational
 
Zollinger Ellison Syndrome
 
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
December 2007
 
  • 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001241
 
890015, 89-DK-0015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
 
National Institutes of Health Clinical Center (CC)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP