Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001241
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Treatment of Zollinger-Ellison Syndrome
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Medical Therapy of Zollinger-Ellison Syndrome
Status:
COMPLETED
Status Verified Date:
2007-12-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 89-DK-0015 | None | None | None |