search
Back to results

Treatment of Zollinger-Ellison Syndrome

Primary Purpose

Zollinger Ellison Syndrome

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Zollinger Ellison Syndrome focused on measuring Gastric Acid Secretion, Histamine H2-Receptor Antagonists

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001241
Brief Title
Treatment of Zollinger-Ellison Syndrome
Official Title
Medical Therapy of Zollinger-Ellison Syndrome
Study Type
Observational

2. Study Status

Record Verification Date
December 10, 2007
Overall Recruitment Status
Completed
Study Start Date
January 27, 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 10, 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zollinger Ellison Syndrome
Keywords
Gastric Acid Secretion, Histamine H2-Receptor Antagonists

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22304
Citation
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. doi: 10.7326/0003-4819-87-6-668.
Results Reference
background

Learn more about this trial

Treatment of Zollinger-Ellison Syndrome

We'll reach out to this number within 24 hrs