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This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.
This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. Patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. Following an initial Screening Visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. Study procedures will include a flexible sigmoidoscopy at the Screening Visit and at the Week 6 visit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deligoparin | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGMG Clinical Research | Anaheim | California | 92801 | United States | ||
| Community Clinical Trials |
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| Orange |
| California |
| 92868 |
| United States |
| Rocky Mountain Gastroenterology Associates | Lakewood | Colorado | 80215 | United States |
| Rocky Mountain Clinical Research | Littleton | Colorado | 80120 | United States |
| University of Florida Gainesville/Gainesville VAMC | Gainesville | Florida | 32608 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32223 | United States |
| University of Miami, Division of Clinical Pharmacology | Miami | Florida | 33136 | United States |
| Miami Research Associates | Miami | Florida | 33173 | United States |
| Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia | 30342 | United States |
| Univ. of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| Metropolitan Gastroenterology Group | Chevy Chase | Maryland | 20815 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Clinical Research Center | Saint Paul | Minnesota | 55114 | United States |
| Washington Univ. School of Medicine | St Louis | Missouri | 63110 | United States |
| Gastroenterology Specialties, PC | Lincoln | Nebraska | 68503 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| Daniel H. Present, MD | New York | New York | 10028 | United States |
| Univ. of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28207 | United States |
| Duke Health Center | Durham | North Carolina | 27710 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | United States |
| West Hills Gastroenterology | Portland | Oregon | 97225 | United States |
| Hospital of the Univ. of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Memphis Gastroenterology Group, PC | Memphis | Tennessee | 38120 | United States |
| Nashville Clinical Research | Nashville | Tennessee | 37211 | United States |
| GANT Research, PA | Fort Worth | Texas | 76102 | United States |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
| Univ. of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Wisconsin Center for Advanced Research, LLC | Milwaukee | Wisconsin | 53207 | 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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