Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

NCT ID: NCT00239551

Last Updated: 2013-07-31

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Stomach Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prevacid

Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 \& EGD at 8 weeks

Group Type EXPERIMENTAL

Prevacid

Intervention Type DRUG

Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 \& EGD with biopsy at 8 weeks

Interventions

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Prevacid

Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 \& EGD with biopsy at 8 weeks

Intervention Type DRUG

Other Intervention Names

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Lansoprazole

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Qiang Cai MD/PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Cai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Vincent W Yang, MD, PhD

Role: STUDY_DIRECTOR

Emory University

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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623-2005

Identifier Type: -

Identifier Source: org_study_id

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