NCT00001241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1989

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 1989

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Zollinger Ellison Syndrome

Keywords

Gastric Acid SecretionHistamine H2-Receptor Antagonists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 22304BACKGROUND

MeSH Terms

Conditions

Zollinger-Ellison Syndrome

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

January 27, 1989

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations

US(1)