Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037570
• Other study ID #: 3001K2-201
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2002
• Last updated: February 7, 2013
• Start date: November 2000
• Est. completion date: February 2002

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Drug:
• Pantoprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States,