Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
Information source: Emory University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stomach Ulcer
Intervention: Prevacid (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Qiang Cai, MD, PhD, Principal Investigator, Affiliation: Emory University
Vincent W Yang, MD, PhD, Study Director, Affiliation: Emory University
Overall contact:
Qiang Cai, MD, PhD, Phone: 404-778-4857, Email: qcai@emory.edu
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.
Clinical Details
Official title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: the effect of Prevacid on prostaglandin levels at 8 weeks
Secondary outcome: esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Qiang Cai, MD, PhD, Phone: 404-778-4857, Email: qcai@emory.edu
Emory University School of Medicine, Atlanta, Georgia 30322, United States; Recruiting
Qiang Cai, MD, PhD, Phone: 404-778-4857, Email: qcai@emory.edu
Qiang Cai, MD, PhD, Principal Investigator
Vincent W Yang, MD, PhD, Sub-Investigator
Additional Information
Starting date: October 2005
Last updated: September 11, 2006
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