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Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Primary Purpose

Peptic Ulcer Hemorrhage

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcer Hemorrhage focused on measuring Peptic, Ulcer, Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2002
    Last Updated
    February 7, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00040495
    Brief Title
    Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
    Official Title
    An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    January 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peptic Ulcer Hemorrhage
    Keywords
    Peptic, Ulcer, Hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Enrollment
    149 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pantoprazole

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

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