Fecal Biomarker Study for Patients With Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00780507
• Lead Sponsor: Warner Chilcott

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

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Exclusion Criteria

• Meet the QDIEM Protocol 2007021 for Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Facility; 🇺🇸 Spokane, Washington, United States