Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

This study has been completed.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: June 26, 2002
Last updated: February 7, 2013
Last verified: February 2013
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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Prevention
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:

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

Enrollment: 149
Study Start Date: April 2001
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

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

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
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Please refer to this study by its identifier: NCT00040495

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00040495     History of Changes
Other Study ID Numbers: 3001K2-315
Study First Received: June 26, 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:

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Intestinal Diseases
Pathologic Processes
Stomach Diseases
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses processed this record on November 30, 2015