The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid

NCT00001191 | Completed Phase 2

• 2 other identifiers: 83001883-DK-0018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous control of their gastric acid secretion. If gastric acid levels are permitted to rise higher than normal, patients may develop severe ulcers and other complications. This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to decrease the amount of gastric acid secreted. Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests. The proper dose of Omeprazole will then be determined in each patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level. Every year patients participating in this study will undergo a physical examination and history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome. Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy. The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion.

Conditions

Gastrinoma; Zollinger Ellison Syndrome

Keywords

Zollinger-Ellison Syndrome; Gastrinoma; Acid Hypersecretion; H+-K+ ATPase Inhibitor

Interventions

Pantoprazole DRUG

Omeprazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects for receiving oral Omeprazole will be patients who have idiopathic gastric acid hypersecretion with basal rates of gastric acid secretion of greater than 15 mEq/hr and patients with Zollinger-Ellison syndrome with basal acid output greater than 10mEq/hr are eligible.
• Subjects with gastric acid hypersecretory states who are being treated with various antisecretory drugs under the protocols entitled "Medical Therapy of Zollinger-Ellison Syndrome" (89-DK-0015) are eligible.
• Patients must be 18 years of age or older.

You may not qualify if:

• Female patients of childbearing age who are attempting to become pregnant, are pregnant, or are unwilling to practice effective birth control will be excluded.
• Patients who develop adverse reactions or allergic responses to Omeprazole will be excluded.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Richardson CT, Walsh JH. The value of a histamine H2-receptor antagonist in the management of patients with the Zollinger-Ellison syndrome. N Engl J Med. 1976 Jan 15;294(3):133-5. doi: 10.1056/NEJM197601152940304.

  PMID: 616 BACKGROUND

MeSH Terms

Conditions

Gastrinoma; Zollinger-Ellison Syndrome

Interventions

Pantoprazole; Omeprazole

Condition Hierarchy (Ancestors)

Carcinoma, Islet Cell; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 3, 1983
• Study Completion: December 10, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-12-10

Locations

US (1)