ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00239551
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Dr. Qiang Cai MD/PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Stomach Ulcer Drug: Prevacid Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
Study Start Date : October 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the effect of Prevacid on prostaglandin levels at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Qiang Cai MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00239551     History of Changes
Other Study ID Numbers: 623-2005
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Dr. Qiang Cai MD/PhD, Emory University:
gastric stress ulcer
Prevacid
Prostaglandin

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action