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”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Oral PPI
• Active Comparator: 2
  • Intravenous PPI

Primary Measures

• Intragastric pH > 6
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• Mean intragastric pH
  • Time Frame: 24 hrs
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Southern California

Overall Clinical Trial Officials and Contacts

Loren Laine, M.D. Principal Investigator University of Southern California  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573924

Study ID Number: HS-06-00014

ClinicalTrials.gov Identifier: NCT00573924

Health Authority: United States: Institutional Review Board