NCT00239551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

October 13, 2005

Last Update Submit

July 29, 2013

Conditions

Stomach Ulcer

Keywords

gastric stress ulcerPrevacidProstaglandin

Outcome Measures

Primary Outcomes (1)

  • the effect of Prevacid on prostaglandin levels at 8 weeks

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (1)

Prevacid

EXPERIMENTAL

Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 \& EGD at 8 weeks

Drug: Prevacid

Interventions

PrevacidDRUG

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

Also known as: Lansoprazole
Prevacid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stomach UlcerDuodenal Ulcer

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Qiang Cai, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Vincent W Yang, MD, PhD

    Emory University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2006

Study Completion

December 1, 2007

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)