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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

December 5, 2006
March 19, 2008
November 2006
November 2007   (final data collection date for primary outcome measure)
Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00409396 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ulcerative Colitis
  • 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.
Experimental: 1
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
Interventions:
  • Procedure: Urinary PGEm level
  • Procedure: fecal calprotectin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00409396
Urinary PGE-M UC
No
David A Schwartz, MD, VUMC
Vanderbilt University
Procter and Gamble
Principal Investigator: David A. Schwartz, MD Vanderbilt University
Vanderbilt University
March 2008

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