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

NCT00573924 | Completed

• 1 other identifier: HS-06-00014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Intragastric pH > 6

  24 hours

Secondary Outcomes (1)

• Mean intragastric pH

  24 hrs

Study Arms (2)

1

ACTIVE COMPARATOR

Oral PPI

Drug: Proton pump inhibitor (lansoprazole)

2

ACTIVE COMPARATOR

Intravenous PPI

Drug: Proton pump inhibitor (lansoprazole)

Interventions

Proton pump inhibitor (lansoprazole) DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy

You may not qualify if:

• Previous gastric surgery
• Active bleeding at end of endoscopy (despite hemostatic therapy)
• Recent PPI or H2RA use

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

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

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.

  PMID: 18423628 RESULT

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Proton Pump Inhibitors; Lansoprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Loren Laine, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: February 1, 2006
• Study Completion: December 1, 2007
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

US (1)