Fecal Biomarker Study for Patients With Ulcerative Colitis

May 29, 2013 updated by: Warner Chilcott

Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study

The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Lowell, Arkansas, United States, 72745
        • Research Facility
    • California
      • Anaheim, California, United States, 92801
        • Research Facility
      • Folsom, California, United States, 95630
        • Research Facility
      • Los Angeles, California, United States, 90045
        • Research Facility
      • Merced, California, United States, 95340
        • Research Facility
      • San Diego, California, United States, 92117
        • Research Facility
      • Upland, California, United States, 91786
        • Research Facility
    • Colorado
      • Lafayette, Colorado, United States, 80026
        • Research Facility
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Research Facility
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • Research Facility
      • New Port Richey, Florida, United States, 34655
        • Research Facility
      • Palm Harbor, Florida, United States, 34684
        • Research Facility
      • Tampa, Florida, United States, 33613
        • Research Facility
      • Zephyrhills, Florida, United States, 33542
        • Research Facility
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Research Facility
      • Marietta, Georgia, United States, 30067
        • Research Facility
      • Newnan, Georgia, United States, 30263
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Research Facility
      • Oak Lawn, Illinois, United States, 60453
        • Research Facility
      • Urbana, Illinois, United States, 61801
        • Research Facility
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Research Facility
    • Iowa
      • Clive, Iowa, United States, 50325
        • Research Facility
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Research Facility
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Research Facility
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Research Facility
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Research Facility
    • Massachusetts
      • Braintree, Massachusetts, United States, 02184
        • Research Facility
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Research Facility
      • Rochester Hills, Michigan, United States, 48307
        • Research Facility
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Facility
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Research Facility
    • New York
      • Babylon, New York, United States, 11702
        • Research Facility
      • Binghamton, New York, United States, 13903
        • Research Facility
      • Cheektowaga, New York, United States, 14225
        • Research Facility
      • Forest Hills, New York, United States, 11375
        • Research Facility
      • Lake Success, New York, United States, 11042
        • Research Facility
      • Pittsford, New York, United States, 14534
        • Research Facility
      • Port Jefferson Station, New York, United States, 11776
        • Research Facility
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • Research Facility
      • Morganton, North Carolina, United States, 28655
        • Research Facility
      • New Bern, North Carolina, United States, 28562
        • Research Facility
      • Raleigh, North Carolina, United States, 27607
        • Research Facility
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Facility
      • Cincinnati, Ohio, United States, 45242
        • Research Facility
      • Cincinnati, Ohio, United States, 45219
        • Research Facility
    • Pennsylvania
      • Indiana, Pennsylvania, United States, 15701
        • Research Facility
      • Lancaster, Pennsylvania, United States, 17604
        • Research Facility
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Research Facility
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Research Facility
    • Texas
      • Greenville, Texas, United States, 75401
        • Research Facility
      • Houston, Texas, United States, 77004
        • Research Facility
      • Houston, Texas, United States, 77090
        • Research Facility
      • Lewisville, Texas, United States, 75057
        • Research Facility
      • Longview, Texas, United States, 75605
        • Research Facility
      • Odessa, Texas, United States, 79761
        • Research Facility
      • Pasadena, Texas, United States, 77504
        • Research Facility
      • Plano, Texas, United States, 75075
        • Research Facility
    • Virginia
      • Alexandria, Virginia, United States, 22306
        • Research Facility
      • Chesapeake, Virginia, United States, 23320
        • Research Facility
      • Winchester, Virginia, United States, 22601
        • Research Facility
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population of ulcerative colitis patients willcome from clients within the United States and are participants in the QDIEM Asacol study (2007021/NCT00505778)

Description

Inclusion Criteria:

  • Be willing and able to provide written informed consent for this biomarker study;
  • Be enrolled in Study 2007021 (QDIEM).

Exclusion Criteria:

  • Meet the QDIEM Protocol 2007021 for Exclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients are in a state of remission
2
Patients are in a flare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the fecal levels of the 2 biomarkers (FC and FL) in patients who are on BID and QD treatment regimens and who remain in remission for the duration of the study;
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: William S Aronstein, MD, PhD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

October 24, 2008

First Posted (Estimate)

October 27, 2008

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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