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...
Date First Received: May 17, 2002
Last Updated: May 17, 2006
Verified by: Wyeth, May 2006
Clinical Trial Phase: Phase 2 | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Prevention, Randomized
Intervention(s) in this Clinical Trial
- Drug: Pantoprazole
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor, MD Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00037570
Study ID Number: 3001K2-201
ClinicalTrials.gov Identifier: NCT00037570
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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