Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

September 11, 2006

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

the effect of Prevacid on prostaglandin levels at 8 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00239551 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

Official Title ^ICMJE

Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer

Brief Summary

The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

Detailed Description

The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.

We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.

Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Stomach Ulcer

Intervention ^ICMJE

Drug: Prevacid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
Patients not on any PPI for 4 weeks prior to the study;
Patients or family be consented for the study.

Exclusion Criteria:

Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
Patients have gastric cancer confirmed by pathology;
Patients on one of the PPIs already;
Patients on any of the Non-steroidal Antiinflammatory Drugs.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Qiang Cai, MD, PhD

404-778-4857

qcai@emory.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00239551

Responsible Party

Study ID Numbers ^ICMJE

623-2005

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

TAP Pharmaceutical Products Inc.

Investigators ^ICMJE

Principal Investigator:	Qiang Cai, MD, PhD	Emory University
Study Director:	Vincent W Yang, MD, PhD	Emory University

Information Provided By

Emory University

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP