Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peptic Ulcer Hemorrhage
Intervention: Pantoprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer
Study design: Prevention, Randomized
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
San Diego, California 62103-8401, United States
Los Angeles, California 90073, United States
Cincinnati, Ohio 45267-0595, United States
Philadelphia, Pennsylvania 19140, United States
Houston, Texas 77030-4211, United States
Norfolk, Virginia 23507, United States
Additional Information
Last updated: May 17, 2006
|
