Fecal Biomarker Study for Patients With Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00780507
First received: October 24, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Phase
Ulcerative Colitis
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Human feces protein biomarkers Enrollment is number of specimens rather than number of subjects


Enrollment: 89
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients are in a state of remission
2
Patients are in a flare

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780507

  Show 61 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: William S Aronstein, MD, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00780507     History of Changes
Other Study ID Numbers: 2007096
Study First Received: October 24, 2008
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014