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

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ClinicalTrials.gov Identifier: NCT00573924
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:
University of Southern California

Brief Summary:
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 or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: Proton pump inhibitor (lansoprazole) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Intragastric pH > 6 [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Mean intragastric pH [ Time Frame: 24 hrs ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011

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