- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037570
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90073
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San Diego, California, United States, 62103-8401
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Ohio
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Cincinnati, Ohio, United States, 45267-0595
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
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Texas
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Houston, Texas, United States, 77030-4211
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Virginia
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Norfolk, Virginia, United States, 23507
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2000
Primary Completion (Actual)
February 1, 2002
Study Completion (Actual)
February 1, 2002
Study Registration Dates
First Submitted
May 17, 2002
First Submitted That Met QC Criteria
May 17, 2002
First Posted (Estimate)
May 20, 2002
Study Record Updates
Last Update Posted (Estimate)
February 8, 2013
Last Update Submitted That Met QC Criteria
February 7, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Gastrointestinal Hemorrhage
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Peptic Ulcer Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Pantoprazole
Other Study ID Numbers
- 3001K2-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peptic Ulcer Hemorrhage
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Uayporn KaosombatwattanaCompleted
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Kaohsiung Veterans General Hospital.Completed
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AstraZenecaCompleted
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Chinese University of Hong KongNational Taiwan University Hospital; Okayama University; Tokyo University; Tsuyama... and other collaboratorsCompletedBleeding Peptic UlcerChina
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Azienda USL ModenaRecruiting
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National Cheng-Kung University HospitalNational Science Council, TaiwanCompleted
-
Odense University HospitalRegion of Southern DenmarkUnknownBleeding Peptic UlcerDenmark
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Chinese University of Hong KongUnknown
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AdventHealthCompletedPeptic Ulcer Hemorrhage | Peptic Ulcer, Acute With HemorrhageUnited States
Clinical Trials on Pantoprazole
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AbbottCompleted
-
Kwong Wah HospitalCompleted
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Alexandria UniversityCompletedPortal Hypertension | Variceal Hemorrhage | Ulcer HemorrhageEgypt
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PfizerRecruitingEsophagitisBelgium, United States, United Kingdom, Serbia, Georgia, Hungary, Bosnia and Herzegovina, Puerto Rico, Turkey, Slovakia, India
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National Taiwan University HospitalUnknownBleeding | Peptic Ulcer | Endoscopy | Proton Pump InhibitorsTaiwan
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TakedaWithdrawnGastric pH ControlMexico
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University of Auckland, New ZealandCompletedBreast Cancer | Chemotherapy-induced Nausea and Vomiting | OncologyNew Zealand
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Wyeth is now a wholly owned subsidiary of PfizerCompletedGastroesophageal Reflux
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PfizerTerminatedGastroesophageal Reflux DiseaseUnited States, Bosnia and Herzegovina, Slovakia, Italy, Germany, Argentina, Georgia, Serbia, Ukraine
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Emory UniversityWyeth is now a wholly owned subsidiary of PfizerCompleted