Trial of Oral Versus Intravenous Proton Pump Inhibitor on... | NCT00573924

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

NCT00573924

Sponsor

University of Southern California

Status

Completed

Last Update Posted

Feb 8, 2011Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Peptic Ulcer Hemorrhage

Interventions

Proton pump inhibitor (lansoprazole)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HS-06-00014

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Dec 13, 2007

First Submission Date that Met QC Criteria

Dec 13, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2011

Last Update Posted Date

Feb 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Oral PPI	Drug: Proton pump inhibitor (lansoprazole)
2	Active Comparator	Intravenous PPI	Drug: Proton pump inhibitor (lansoprazole)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	1 2

Measure	Description	Time Frame
Intragastric pH > 6		24 hours

Measure	Description	Time Frame
Mean intragastric pH		24 hrs

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
L.A. County + U.S.C. Medical Center		Los Angeles	California	90033	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18423628	Result	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.

ID	Term
D006471	Gastrointestinal Hemorrhage
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage

ID	Term
D054328	Proton Pump Inhibitors
D064747	Lansoprazole

ID	Term
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses