Fecal Biomarker Study for Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780507
• Other study ID #: 2007096
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2008
• Last updated: May 29, 2013
• Start date: August 2007
• Est. completion date: July 2009

Study information

• Verified date: May 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Research Facility	Alexandria	Virginia
United States	Research Facility	Anaheim	California
United States	Research Facility	Arlington Heights	Illinois
United States	Research Facility	Babylon	New York
United States	Research Facility	Binghamton	New York
United States	Research Facility	Boone	North Carolina
United States	Research Facility	Bowling Green	Kentucky
United States	Research Facility	Braintree	Massachusetts
United States	Research Facility	Canton	Ohio
United States	Research Facility	Cheektowaga	New York
United States	Research Facility	Chesapeake	Virginia
United States	Research Facility	Chesterfield	Michigan
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Clive	Iowa
United States	Research Facility	Decatur	Georgia
United States	Research Facility	Egg Harbor Township	New Jersey
United States	Research Facility	Folsom	California
United States	Research Facility	Forest Hills	New York
United States	Research Facility	Ft. Lauderdale	Florida
United States	Research Facility	Greenville	Texas
United States	Research Facility	Houston	Texas
United States	Research Facility	Houston	Texas
United States	Research Facility	Indiana	Pennsylvania
United States	Research Facility	Jackson	Tennessee
United States	Research Facility	Jefferson City	Missouri
United States	Research Facility	Lafayette	Colorado
United States	Research Facility	Lake Success	New York
United States	Research Facility	Lancaster	Pennsylvania
United States	Research Facility	Lewisville	Texas
United States	Research Facility	Longview	Texas
United States	Research Facility	Los Angeles	California
United States	Research Facility	Lowell	Arkansas
United States	Research Facility	Lutherville	Maryland
United States	Research Facility	Marietta	Georgia
United States	Research Facility	Merced	California
United States	Research Facility	Morganton	North Carolina
United States	Research Facility	New Bern	North Carolina
United States	Research Facility	New Port Richey	Florida
United States	Research Facility	Newnan	Georgia
United States	Research Facility	Oak Lawn	Illinois
United States	Research Facility	Odessa	Texas
United States	Research Facility	Palm Harbor	Florida
United States	Research Facility	Pasadena	Texas
United States	Research Facility	Pittsford	New York
United States	Research Facility	Plano	Texas
United States	Research Facility	Port Jefferson Station	New York
United States	Research Facility	Raleigh	North Carolina
United States	Research Facility	Rochester Hills	Michigan
United States	Research Facility	San Diego	California
United States	Research Facility	Shreveport	Louisiana
United States	Research Facility	South Bend	Indiana
United States	Research Facility	Spokane	Washington
United States	Research Facility	Tampa	Florida
United States	Research Facility	Topeka	Kansas
United States	Research Facility	Torrington	Connecticut
United States	Research Facility	Upland	California
United States	Research Facility	Urbana	Illinois
United States	Research Facility	Warwick	Rhode Island
United States	Research Facility	Winchester	Virginia
United States	Research Facility	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No