Fecal Biomarker Study for Patients With Ulcerative Colitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00780507

Enrollment

Registered

2008-10-27

Start date

2007-08-31

Completion date

2009-07-31

Last updated

2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results