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

NCT ID: NCT00573924

Last Updated: 2011-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral PPI

Group Type ACTIVE_COMPARATOR

Proton pump inhibitor (lansoprazole)

Intervention Type 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

2

Intravenous PPI

Group Type ACTIVE_COMPARATOR

Proton pump inhibitor (lansoprazole)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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University of Southern California

Principal Investigators

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Loren Laine, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18423628 (View on PubMed)

Other Identifiers

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HS-06-00014

Identifier Type: -

Identifier Source: secondary_id

HS-06-00014

Identifier Type: -

Identifier Source: org_study_id

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