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

This study has been completed.
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00573924
First received: December 13, 2007
Last updated: February 4, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Peptic Ulcer Hemorrhage
Drug: Proton pump inhibitor (lansoprazole)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Intragastric pH > 6 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean intragastric pH [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: February 2006
Study Completion Date: December 2007
Arms Assigned Interventions
Active Comparator: 1
Oral PPI
Drug: Proton pump inhibitor (lansoprazole)
  1. 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs
  2. 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs
Active Comparator: 2
Intravenous PPI
Drug: Proton pump inhibitor (lansoprazole)
  1. 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs
  2. 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573924

Locations
United States, California
L.A. County + U.S.C. Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Loren Laine, M.D. University of Southern California
  More Information

Publications:
Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT00573924     History of Changes
Other Study ID Numbers: HS-06-00014, HS-06-00014
Study First Received: December 13, 2007
Last Updated: February 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014