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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients are in a state of remission | ||
| 2 | Patients are in a flare |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The population of ulcerative colitis patients willcome from clients within the United States and are participants in the QDIEM Asacol study (2007021/NCT00505778)
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| Name | Affiliation | Role |
|---|---|---|
| William S Aronstein, MD, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Lowell | Arkansas | 72745 | United States | ||
| Research Facility |
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Human feces protein biomarkers Enrollment is number of specimens rather than number of subjects
| Anaheim |
| California |
| 92801 |
| United States |
| Research Facility | Folsom | California | 95630 | United States |
| Research Facility | Los Angeles | California | 90045 | United States |
| Research Facility | Merced | California | 95340 | United States |
| Research Facility | San Diego | California | 92117 | United States |
| Research Facility | Upland | California | 91786 | United States |
| Research Facility | Lafayette | Colorado | 80026 | United States |
| Research Facility | Torrington | Connecticut | 06790 | United States |
| Research Facility | Fort Lauderdale | Florida | 33308 | United States |
| Research Facility | New Port Richey | Florida | 34655 | United States |
| Research Facility | Palm Harbor | Florida | 34684 | United States |
| Research Facility | Tampa | Florida | 33613 | United States |
| Research Facility | Zephyrhills | Florida | 33542 | United States |
| Research Facility | Decatur | Georgia | 30033 | United States |
| Research Facility | Marietta | Georgia | 30067 | United States |
| Research Facility | Newnan | Georgia | 30263 | United States |
| Research Facility | Arlington Heights | Illinois | 60005 | United States |
| Research Facility | Oak Lawn | Illinois | 60453 | United States |
| Research Facility | Urbana | Illinois | 61801 | United States |
| Research Facility | South Bend | Indiana | 46601 | United States |
| Research Facility | Clive | Iowa | 50325 | United States |
| Research Facility | Topeka | Kansas | 66606 | United States |
| Research Facility | Bowling Green | Kentucky | 42101 | United States |
| Research Facility | Shreveport | Louisiana | 71103 | United States |
| Research Facility | Lutherville | Maryland | 21093 | United States |
| Research Facility | Braintree | Massachusetts | 02184 | United States |
| Research Facility | Chesterfield | Michigan | 48047 | United States |
| Research Facility | Rochester Hills | Michigan | 48307 | United States |
| Research Facility | Jefferson City | Missouri | 65109 | United States |
| Research Facility | Egg Harbor | New Jersey | 08234 | United States |
| Research Facility | Babylon | New York | 11702 | United States |
| Research Facility | Binghamton | New York | 13903 | United States |
| Research Facility | Cheektowaga | New York | 14225 | United States |
| Research Facility | Forest Hills | New York | 11375 | United States |
| Research Facility | Lake Success | New York | 11042 | United States |
| Research Facility | Pittsford | New York | 14534 | United States |
| Research Facility | Port Jefferson Station | New York | 11776 | United States |
| Research Facility | Boone | North Carolina | 28607 | United States |
| Research Facility | Morganton | North Carolina | 28655 | United States |
| Research Facility | New Bern | North Carolina | 28562 | United States |
| Research Facility | Raleigh | North Carolina | 27607 | United States |
| Research Facility | Canton | Ohio | 44718 | United States |
| Research Facility | Cincinnati | Ohio | 45219 | United States |
| Research Facility | Cincinnati | Ohio | 45242 | United States |
| Research Facility | Indiana | Pennsylvania | 15701 | United States |
| Research Facility | Lancaster | Pennsylvania | 17604 | United States |
| Research Facility | Warwick | Rhode Island | 02888 | United States |
| Research Facility | Jackson | Tennessee | 38301 | United States |
| Research Facility | Greenville | Texas | 75401 | United States |
| Research Facility | Houston | Texas | 77004 | United States |
| Research Facility | Houston | Texas | 77090 | United States |
| Research Facility | Lewisville | Texas | 75057 | United States |
| Research Facility | Longview | Texas | 75605 | United States |
| Research Facility | Odessa | Texas | 79761 | United States |
| Research Facility | Pasadena | Texas | 77504 | United States |
| Research Facility | Plano | Texas | 75075 | United States |
| Research Facility | Alexandria | Virginia | 22306 | United States |
| Research Facility | Chesapeake | Virginia | 23320 | United States |
| Research Facility | Winchester | Virginia | 22601 | United States |
| Research Facility | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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