Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

Completed · Phase 2/Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00033943

Run by

Incara Pharmaceuticals

People needed

270

Starts

2001-01-01

Expected to finish

2002-09-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.
• Treatment with aminosalicylates at least 28 days, if tolerated.
• Duration of current flare-up at least 7 days.
• Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.

You may not qualify if…

• Disease limited to the rectum.
• Toxic megacolon.
• The use of anticoagulant drugs.
• A history of any bleeding disorder.
• A history of heparin-induced thrombocytopenia.
• Evidence of liver or kidney impairment.
• Women who are pregnant or breast feeding.

Where it is running

• AGMG Clinical Research — Anaheim, California, United States
• Community Clinical Trials — Orange, California, United States
• Rocky Mountain Gastroenterology Associates — Lakewood, Colorado, United States
• Rocky Mountain Clinical Research — Littleton, Colorado, United States
• University of Florida Gainesville/Gainesville VAMC — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• University of Miami, Division of Clinical Pharmacology — Miami, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States
• Univ. of Kentucky Medical Center — Lexington, Kentucky, United States
• Metropolitan Gastroenterology Group — Chevy Chase, Maryland, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Minnesota Clinical Research Center — Saint Paul, Minnesota, United States
• Washington Univ. School of Medicine — St Louis, Missouri, United States
• Gastroenterology Specialties, PC — Lincoln, Nebraska, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• Daniel H. Present, MD — New York, New York, United States
• Univ. of North Carolina Hospital — Chapel Hill, North Carolina, United States
• Charlotte Gastroenterology & Hepatology, PLLC — Charlotte, North Carolina, United States
• Duke Health Center — Durham, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oklahoma Foundation for Digestive Research — Oklahoma City, Oklahoma, United States
• Gastroenterology United of Tulsa — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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