Fecal Biomarker Study for Patients With Ulcerative Colitis

NCT ID: NCT00780507

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients are in a state of remission

No interventions assigned to this group

2

Patients are in a flare

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William S Aronstein, MD, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Lowell, Arkansas, United States

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Anaheim, California, United States

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Folsom, California, United States

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Los Angeles, California, United States

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Merced, California, United States

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San Diego, California, United States

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Upland, California, United States

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Lafayette, Colorado, United States

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Torrington, Connecticut, United States

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Fort Lauderdale, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Newnan, Georgia, United States

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Arlington Heights, Illinois, United States

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Oak Lawn, Illinois, United States

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Urbana, Illinois, United States

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South Bend, Indiana, United States

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Clive, Iowa, United States

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Topeka, Kansas, United States

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Bowling Green, Kentucky, United States

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Shreveport, Louisiana, United States

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Lutherville, Maryland, United States

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Braintree, Massachusetts, United States

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Chesterfield, Michigan, United States

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Rochester Hills, Michigan, United States

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Jefferson City, Missouri, United States

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Egg Harbor, New Jersey, United States

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Babylon, New York, United States

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Binghamton, New York, United States

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Cheektowaga, New York, United States

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Forest Hills, New York, United States

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Lake Success, New York, United States

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Pittsford, New York, United States

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Port Jefferson Station, New York, United States

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Boone, North Carolina, United States

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Morganton, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Indiana, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Jackson, Tennessee, United States

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Greenville, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lewisville, Texas, United States

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Longview, Texas, United States

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Odessa, Texas, United States

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Pasadena, Texas, United States

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Plano, Texas, United States

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Alexandria, Virginia, United States

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Chesapeake, Virginia, United States

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Winchester, Virginia, United States

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Spokane, Washington, United States

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Countries

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United States

Other Identifiers

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2007096

Identifier Type: -

Identifier Source: org_study_id

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