An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Sponsors

Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Source Wyeth is now a wholly owned subsidiary of Pfizer
Brief Summary

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.

Overall Status Completed
Start Date April 2001
Completion Date January 2003
Primary Completion Date January 2003
Phase Phase 3
Study Type Interventional
Enrollment 149
Condition
Intervention

Intervention type: Drug

Intervention name: Pantoprazole

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor, MD Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date

February 2013

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Prevention

Source: ClinicalTrials.gov