Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

Stomach Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239551
• Other study ID #: 623-2005
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: July 29, 2013
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: July 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of Prevacid on prostaglandin levels at 8 weeks		8 weeks	No
Secondary	esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks		8 weeks	No