Clinical trial NCT00780507: Fecal Biomarker Study for Patients With Ulcerative Colitis
Official title: Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: one year
Secondary outcomes:
measure: 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;
timeFrame: one year
Other outcomes:
Locations:
city: Lowell
country: United States
facility: Research Facility
state: Arkansas
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Folsom
country: United States
facility: Research Facility
state: California
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Merced
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: Upland
country: United States
facility: Research Facility
state: California
city: Lafayette
country: United States
facility: Research Facility
state: Colorado
city: Torrington
country: United States
facility: Research Facility
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Research Facility
state: Florida
city: New Port Richey
country: United States
facility: Research Facility
state: Florida
city: Palm Harbor
country: United States
facility: Research Facility
state: Florida
city: Tampa
country: United States
facility: Research Facility
state: Florida
city: Zephyrhills
country: United States
facility: Research Facility
state: Florida
city: Decatur
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Newnan
country: United States
facility: Research Facility
state: Georgia
city: Arlington Heights
country: United States
facility: Research Facility
state: Illinois
city: Oak Lawn
country: United States
facility: Research Facility
state: Illinois
city: Urbana
country: United States
facility: Research Facility
state: Illinois
city: South Bend
country: United States
facility: Research Facility
state: Indiana
city: Clive
country: United States
facility: Research Facility
state: Iowa
city: Topeka
country: United States
facility: Research Facility
state: Kansas
city: Bowling Green
country: United States
facility: Research Facility
state: Kentucky
city: Shreveport
country: United States
facility: Research Facility
state: Louisiana
city: Lutherville
country: United States
facility: Research Facility
state: Maryland
city: Braintree
country: United States
facility: Research Facility
state: Massachusetts
city: Chesterfield
country: United States
facility: Research Facility
state: Michigan
city: Rochester Hills
country: United States
facility: Research Facility
state: Michigan
city: Jefferson City
country: United States
facility: Research Facility
state: Missouri
city: Egg Harbor Township
country: United States
facility: Research Facility
state: New Jersey
city: Babylon
country: United States
facility: Research Facility
state: New York
city: Binghamton
country: United States
facility: Research Facility
state: New York
city: Cheektowaga
country: United States
facility: Research Facility
state: New York
city: Forest Hills
country: United States
facility: Research Facility
state: New York
city: Lake Success
country: United States
facility: Research Facility
state: New York
city: Pittsford
country: United States
facility: Research Facility
state: New York
city: Port Jefferson Station
country: United States
facility: Research Facility
state: New York
city: Boone
country: United States
facility: Research Facility
state: North Carolina
city: Morganton
country: United States
facility: Research Facility
state: North Carolina
city: New Bern
country: United States
facility: Research Facility
state: North Carolina
city: Raleigh
country: United States
facility: Research Facility
state: North Carolina
city: Canton
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Indiana
country: United States
facility: Research Facility
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Facility
state: Pennsylvania
city: Warwick
country: United States
facility: Research Facility
state: Rhode Island
city: Jackson
country: United States
facility: Research Facility
state: Tennessee
city: Greenville
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Lewisville
country: United States
facility: Research Facility
state: Texas
city: Longview
country: United States
facility: Research Facility
state: Texas
city: Odessa
country: United States
facility: Research Facility
state: Texas
city: Pasadena
country: United States
facility: Research Facility
state: Texas
city: Plano
country: United States
facility: Research Facility
state: Texas
city: Alexandria
country: United States
facility: Research Facility
state: Virginia
city: Chesapeake
country: United States
facility: Research Facility
state: Virginia
city: Winchester
country: United States
facility: Research Facility
state: Virginia
city: Spokane
country: United States
facility: Research Facility
state: Washington
Study officials:
affiliation: Procter and Gamble
name: William S Aronstein, MD, PhD
role: STUDY_DIRECTOR
References: