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NCT Number: NCT00239551

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

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.

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Key information

Conditions

Stomach Ulcer Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevacid

Drug

Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 & EGD with biopsy at 8 weeks

Other names: Lansoprazole

Primary outcomes

  1. the effect of Prevacid on prostaglandin levels at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • TAP Pharmaceutical Products Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Oct 17, 2005
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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