Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer
1 other identifier
interventional
12
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2000
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 17, 2002
CompletedFirst Posted
Study publicly available on registry
May 20, 2002
CompletedFebruary 8, 2013
February 1, 2013
1.3 years
May 17, 2002
February 7, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90073, United States
Unknown Facility
San Diego, California, 62103-8401, United States
Unknown Facility
Cincinnati, Ohio, 45267-0595, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Houston, Texas, 77030-4211, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2002
First Posted
May 20, 2002
Study Start
November 1, 2000
Primary Completion
February 1, 2002
Study Completion
February 1, 2002
Last Updated
February 8, 2013
Record last verified: 2013-02