Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by Emory University. Recruitment status was Recruiting

First Received on October 13, 2005. Last Updated on September 11, 2006 History of Changes

Sponsor:	Emory University
Collaborator:	TAP Pharmaceutical Products Inc.
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00239551

Purpose

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.

Condition	Intervention	Phase
Stomach Ulcer	Drug: Prevacid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer

Resource links provided by NLM:

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

the effect of Prevacid on prostaglandin levels at 8 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239551

Contacts

Contact: Qiang Cai, MD, PhD

404-778-4857

qcai@emory.edu

Locations

United States, Georgia
Emory University School of Medicine	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Qiang Cai, MD, PhD 404-778-4857 qcai@emory.edu
Principal Investigator: Qiang Cai, MD, PhD
Sub-Investigator: Vincent W Yang, MD, PhD

Sponsors and Collaborators

Emory University

TAP Pharmaceutical Products Inc.

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00239551 History of Changes
Other Study ID Numbers:	623-2005
Study First Received:	October 13, 2005
Last Updated:	September 11, 2006
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

gastric stress ulcer
Prevacid
Prostaglandin

Additional relevant MeSH terms:

Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012