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| Sponsor: | Incara Pharmaceuticals |
|---|---|
| Information provided by: | Incara Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00033943 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Drug: deligoparin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis |
| Estimated Enrollment: | 270 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | September 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Community Clinical Trials | |
| Orange, California, United States, 92868 | |
| AGMG Clinical Research | |
| Anaheim, California, United States, 92801 | |
| United States, Colorado | |
| Rocky Mountain Gastroenterology Associates | |
| Lakewood, Colorado, United States, 80215 | |
| Rocky Mountain Clinical Research | |
| Littleton, Colorado, United States, 80120 | |
| United States, Florida | |
| Borland-Groover Clinic | |
| Jacksonville, Florida, United States, 32223 | |
| University of Miami, Division of Clinical Pharmacology | |
| Miami, Florida, United States, 33136 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| University of Florida Gainesville/Gainesville VAMC | |
| Gainesville, Florida, United States, 32608 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates, LLC | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Kentucky | |
| Univ. of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Metropolitan Gastroenterology Group | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Minnesota Clinical Research Center | |
| St. Paul, Minnesota, United States, 55114 | |
| United States, Missouri | |
| Washington Univ. School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Gastroenterology Specialties, PC | |
| Lincoln, Nebraska, United States, 68503 | |
| United States, New York | |
| Daniel H. Present, MD | |
| New York, New York, United States, 10028 | |
| Long Island Clinical Research Associates | |
| Great Neck, New York, United States, 11021 | |
| United States, North Carolina | |
| Univ. of North Carolina Hospital | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke Health Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| Charlotte Gastroenterology & Hepatology, PLLC | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Ohio | |
| Consultants for Clinical Research | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Oklahoma Foundation for Digestive Research | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Gastroenterology United of Tulsa | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Oregon | |
| West Hills Gastroenterology | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Hospital of the Univ. of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Memphis Gastroenterology Group, PC | |
| Memphis, Tennessee, United States, 38120 | |
| Nashville Clinical Research | |
| Nashville, Tennessee, United States, 37211 | |
| United States, Texas | |
| Gastroenterology Clinic of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| GANT Research, PA | |
| Fort Worth, Texas, United States, 76102 | |
| United States, Virginia | |
| Univ. of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Wisconsin | |
| Wisconsin Center for Advanced Research, LLC | |
| Milwaukee, Wisconsin, United States, 53207 | |
More Information
| Study ID Numbers: | OP201 |
| Study First Received: | April 16, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00033943 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |