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

Sponsor:	University of Southern California
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00573924

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:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Lansoprazole

U.S. FDA Resources

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) 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

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:

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. Epub 2008 Mar 10.

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 February 09, 2012