Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

NCT ID: NCT00040495

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-01-31

Brief Summary

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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

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Conditions

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Peptic Ulcer Hemorrhage

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3001K2-315

Identifier Type: -

Identifier Source: org_study_id

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