Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

This study is ongoing, but not recruiting participants.

First Received: June 26, 2002 Last Updated: May 18, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00040495

Purpose

The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.

Condition	Intervention	Phase
Peptic Ulcer Hemorrhage	Drug: Pantoprazole	Phase III

Study Type:	Interventional
Study Design:	Prevention, Safety/Efficacy Study
Official Title:	An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

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 non-pregnant women at least 18 years of age
Patients who present with a gastric or duodenal ulcer

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: NCT00040495

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3001K2-315
Study First Received:	June 26, 2002
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00040495 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Peptic
Ulcer
Hemorrhage

Study placed in the following topic categories:

Gastrointestinal Diseases
Ulcer
Pantoprazole
Gastrointestinal Hemorrhage
Hemorrhage
Intestinal Diseases
Recurrence

Hemostatics
Digestive System Diseases
Stomach Diseases
Peptic Ulcer Hemorrhage
Peptic Ulcer
Duodenal Diseases

Additional relevant MeSH terms:

Gastrointestinal Diseases
Ulcer
Pantoprazole
Gastrointestinal Agents
Gastrointestinal Hemorrhage
Hemorrhage
Intestinal Diseases
Pharmacologic Actions

Pathologic Processes
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Peptic Ulcer Hemorrhage
Anti-Ulcer Agents
Peptic Ulcer
Duodenal Diseases

ClinicalTrials.gov processed this record on July 02, 2009