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Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00037570
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: Pantoprazole Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : November 2000
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00037570


Locations
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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
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00037570    
Other Study ID Numbers: 3001K2-201
First Posted: May 20, 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:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
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