A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

This study has been completed.

Sponsor:

Collaborator:

Procter and Gamble

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00409396

First received: December 5, 2006

Last updated: March 19, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2006

Last Updated Date

March 19, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Urine for PGEm levels at clinic visit when colonoscopy is scheduled
Routine colonoscopy for assessment of disease activity
Mayo disease activity score at time of colonoscopy

Change History

Complete list of historical versions of study NCT00409396 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood for CRP [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ] [ Designated as safety issue: No ]
MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Blood for CRP at clinic visit when colonoscopy is scheduled
Stool for fecal calprotectin at clinic visit when colonoscopy is scheduled or
prior to bowel prep for scheduled colonoscopy

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

Official Title ^ICMJE

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Brief Summary

The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.

Detailed Description

The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Procedure: Urinary PGEm level
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
Procedure: fecal calprotectin
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Study Arm (s)

Experimental: 1

Fecal calprotectin and urinary PGEm levels will be tested on all participants.

Interventions:

Procedure: Urinary PGEm level
Procedure: fecal calprotectin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Outpatient male or female 18 years or older
Confirmed diagnosis of ulcerative colitis
Informed consent obtained
Able to give blood, urine and stool samples
Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care

Exclusion Criteria:

Unable to give consent
Crohn's disease
Does not meet inclusion criteria
Pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00409396

Other Study ID Numbers ^ICMJE

Urinary PGE-M UC

Has Data Monitoring Committee

Responsible Party

David A Schwartz, MD, VUMC

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Procter and Gamble

Investigators ^ICMJE

Principal Investigator:

David A. Schwartz, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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