Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

July 29, 2013 updated by: Dr. Qiang Cai MD/PhD, Emory University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevacid
Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 & EGD at 8 weeks
Drug: Prevacid
Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 & EGD with biopsy at 8 weeks
Other Names:
  • Lansoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the effect of Prevacid on prostaglandin levels at 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

TAP Pharmaceutical Products Inc.

Investigators

  • Study Director: Vincent W Yang, MD, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 623-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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