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

Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage
• Intervention / Treatment: Drug: Proton pump inhibitor (lansoprazole)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • L.A. County + U.S.C. Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Oral PPI	Drug: Proton pump inhibitor (lansoprazole); 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs; 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs
Active Comparator: 2; Intravenous PPI	Drug: Proton pump inhibitor (lansoprazole); 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs; 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intragastric pH > 6	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean intragastric pH	24 hrs

Collaborators and Investigators

• Sponsor: University of Southern California

Publications and helpful links

General Publications

• Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 14, 2007

Study Record Updates

• Last Update Posted (Estimate): February 8, 2011
• Last Update Submitted That Met QC Criteria: February 4, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Dexlansoprazole; Lansoprazole; Proton Pump Inhibitors
• Other Study ID Numbers: HS-06-00014