Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

This study has been completed.

First Received on May 17, 2002. Last Updated on May 17, 2006 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00037570

Purpose

This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.

Condition	Intervention	Phase
Peptic Ulcer Hemorrhage	Drug: Pantoprazole	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Prevention
Official Title:	A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be men or nonpregnant women at least 18 years of age
Patients who present with a gastric or duodenal ulcer (major dimension of the ulcer must be ≥ 5 mm and ≤ 20 mm) with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV) Patients presenting with adherent protruding clot are eligible if, after removal of the clot by irrigation, the underlying lesion is classified as spurting, oozing or a NBVV. Patients with an actively bleeding ulcer or a NBVV within a hiatal hernia are eligible if the ulcer is located below the Z-line)

Exclusion Criteria:

Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
Patients with any severe concomitant diseases, eg, end-stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037570

Locations

United States, California

Los Angeles, California, United States, 90073

San Diego, California, United States, 62103-8401
United States, Ohio

Cincinnati, Ohio, United States, 45267-0595
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19140
United States, Texas

Houston, Texas, United States, 77030-4211
United States, Virginia

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00037570 History of Changes
Other Study ID Numbers:	3001K2-201
Study First Received:	May 17, 2002
Last Updated:	May 17, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Peptic
Ulcer
Hemorrhage

Additional relevant MeSH terms:

Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

Gastrointestinal Hemorrhage
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012