Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage - Tabular View

Tracking Information

First Received Date ^ICMJE

June 26, 2002

Last Updated Date

August 20, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00040495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Official Title ^ICMJE

An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Safety/Efficacy Study

Condition ^ICMJE

Peptic Ulcer Hemorrhage

Intervention ^ICMJE

Drug: Pantoprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00040495

Responsible Party

Study ID Numbers ^ICMJE

3001K2-315

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP