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OpenTrials
Completed

NCT Number: NCT00573924

Trial of Oral Versus Intravenous 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.

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Key information

Conditions

Peptic Ulcer Hemorrhage Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

L.A. County + U.S.C. Medical Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton pump inhibitor (lansoprazole)

Drug
  • 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

Primary outcomes

  1. Intragastric pH > 6

    Time frame: 24 hours

Secondary outcomes

  1. Mean intragastric pH

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 14, 2007
Registry last updated
Feb 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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