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Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

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ClinicalTrials.gov Identifier: NCT00040495
Recruitment Status : Completed
First Posted : June 28, 2002
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Primary Purpose: Prevention
Official Title: An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis
Study Start Date : April 2001
Primary Completion Date : January 2003
Study Completion Date : January 2003

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U.S. FDA Resources





Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040495


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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00040495     History of Changes
Other Study ID Numbers: 3001K2-315
First Posted: June 28, 2002    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

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