Fecal Biomarker Study for Patients With Ulcerative Colitis

NCT00780507 | Completed

• 1 other identifier: 2007096
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 61

Brief Summary

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).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (1)

• 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;

  one year

Study Arms (2)

1

Patients are in a state of remission

2

Patients are in a flare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (61)

Research Facility

Lowell, Arkansas, 72745, United States

Location

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Anaheim, California, 92801, United States

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Folsom, California, 95630, United States

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Los Angeles, California, 90045, United States

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Merced, California, 95340, United States

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San Diego, California, 92117, United States

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Upland, California, 91786, United States

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Lafayette, Colorado, 80026, United States

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Torrington, Connecticut, 06790, United States

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Fort Lauderdale, Florida, 33308, United States

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New Port Richey, Florida, 34655, United States

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Palm Harbor, Florida, 34684, United States

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Tampa, Florida, 33613, United States

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Zephyrhills, Florida, 33542, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30067, United States

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Newnan, Georgia, 30263, United States

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Arlington Heights, Illinois, 60005, United States

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Oak Lawn, Illinois, 60453, United States

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Urbana, Illinois, 61801, United States

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South Bend, Indiana, 46601, United States

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Clive, Iowa, 50325, United States

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Topeka, Kansas, 66606, United States

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Bowling Green, Kentucky, 42101, United States

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Shreveport, Louisiana, 71103, United States

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Lutherville, Maryland, 21093, United States

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Braintree, Massachusetts, 02184, United States

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Chesterfield, Michigan, 48047, United States

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Rochester Hills, Michigan, 48307, United States

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Jefferson City, Missouri, 65109, United States

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Egg Harbor, New Jersey, 08234, United States

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Babylon, New York, 11702, United States

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Binghamton, New York, 13903, United States

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Cheektowaga, New York, 14225, United States

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Forest Hills, New York, 11375, United States

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Lake Success, New York, 11042, United States

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Pittsford, New York, 14534, United States

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Port Jefferson Station, New York, 11776, United States

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Boone, North Carolina, 28607, United States

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Morganton, North Carolina, 28655, United States

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New Bern, North Carolina, 28562, United States

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Raleigh, North Carolina, 27607, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45242, United States

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Indiana, Pennsylvania, 15701, United States

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Lancaster, Pennsylvania, 17604, United States

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Warwick, Rhode Island, 02888, United States

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Jackson, Tennessee, 38301, United States

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Greenville, Texas, 75401, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77090, United States

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Lewisville, Texas, 75057, United States

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Longview, Texas, 75605, United States

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Odessa, Texas, 79761, United States

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Pasadena, Texas, 77504, United States

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Plano, Texas, 75075, United States

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Alexandria, Virginia, 22306, United States

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Chesapeake, Virginia, 23320, United States

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Winchester, Virginia, 22601, United States

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Spokane, Washington, 99204, United States

Location

Biospecimen

Retention: NONE RETAINED

Human feces protein biomarkers Enrollment is number of specimens rather than number of subjects

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• William S Aronstein, MD, PhD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (61)