Fecal Biomarker Study for Patients With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780507
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):
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).

Condition or disease
Ulcerative Colitis

Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study
Study Start Date : August 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Patients are in a state of remission
Patients are in a flare

Primary Outcome Measures :
  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. [ Time Frame: one year ]

Secondary Outcome Measures :
  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; [ Time Frame: one year ]

Biospecimen Retention:   None Retained
Human feces protein biomarkers Enrollment is number of specimens rather than number of subjects

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780507

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Sponsors and Collaborators
Warner Chilcott
Study Director: William S Aronstein, MD, PhD Procter and Gamble

Responsible Party: Warner Chilcott Identifier: NCT00780507     History of Changes
Other Study ID Numbers: 2007096
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases