Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

University of Southern California

Status: Completed

Conditions: Peptic Ulcer Hemorrhage

Treatments: Drug: Proton pump inhibitor (lansoprazole)

Study type: Interventional

Funder types: Other

Identifiers

NCT00573924

HS-06-00014

Details and patient eligibility

About

Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy

Exclusion criteria

• Previous gastric surgery
• Active bleeding at end of endoscopy (despite hemostatic therapy)
• Recent PPI or H2RA use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

1

Active Comparator group

Description:

Oral PPI

Treatment:

Drug: Proton pump inhibitor (lansoprazole)

2

Active Comparator group

Description:

Intravenous PPI

Treatment:

Drug: Proton pump inhibitor (lansoprazole)