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Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

Primary Purpose

Stomach Ulcer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prevacid
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Ulcer focused on measuring gastric stress ulcer, Prevacid, Prostaglandin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevacid

Arm Description

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

Outcomes

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

Full Information

First Posted
October 13, 2005
Last Updated
July 29, 2013
Sponsor
Emory University
Collaborators
TAP Pharmaceutical Products Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00239551
Brief Title
Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
Official Title
Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
TAP Pharmaceutical Products Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer
Keywords
gastric stress ulcer, Prevacid, Prostaglandin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevacid
Arm Type
Experimental
Arm Description
Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 & EGD at 8 weeks
Intervention Type
Drug
Intervention Name(s)
Prevacid
Other Intervention Name(s)
Lansoprazole
Intervention Description
Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 & EGD with biopsy at 8 weeks
Primary Outcome Measure Information:
Title
the effect of Prevacid on prostaglandin levels at 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Cai, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent W Yang, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Study Director
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

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