Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

This study has been completed.
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Dr. Qiang Cai MD/PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00239551
First received: October 13, 2005
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Stomach Ulcer
Drug: Prevacid
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • the effect of Prevacid on prostaglandin levels at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lansoprazole

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239551

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Qiang Cai, MD, PhD Emory University
Study Director: Vincent W Yang, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Dr. Qiang Cai MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00239551     History of Changes
Other Study ID Numbers: 623-2005
Study First Received: October 13, 2005
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
gastric stress ulcer
Prevacid
Prostaglandin

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014