Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00037570

First received: May 17, 2002

Last updated: February 7, 2013

Last verified: February 2013

History of Changes

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 2


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: Bleeding 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:


Enrollment:	12
Study Start Date:	November 2000
Study Completion Date:	February 2002
Primary Completion Date:	February 2002 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00037570 History of Changes
Other Study ID Numbers:	3001K2-201
Study First Received:	May 17, 2002
Last Updated:	February 7, 2013
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:


Ulcer Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases	Stomach Diseases Gastrointestinal Hemorrhage Pantoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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