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	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: deligoparin	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  270

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

California
      Community Clinical Trials, Orange,  California,  92868,  United States
      AGMG Clinical Research, Anaheim,  California,  92801,  United States
Colorado
      Rocky Mountain Gastroenterology Associates, Lakewood,  Colorado,  80215,  United States
      Rocky Mountain Clinical Research, Littleton,  Colorado,  80120,  United States
Florida
      University of Florida Gainesville/Gainesville VAMC, Gainesville,  Florida,  32608,  United States
      University of Miami, Division of Clinical Pharmacology, Miami,  Florida,  33136,  United States
      Miami Research Associates, Miami,  Florida,  33173,  United States
      Borland-Groover Clinic, Jacksonville,  Florida,  32223,  United States
Georgia
      Atlanta Gastroenterology Associates, LLC, Atlanta,  Georgia,  30342,  United States
Kentucky
      Univ. of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States
Maryland
      Metropolitan Gastroenterology Group, Chevy Chase,  Maryland,  20815,  United States
Michigan
      University of Michigan Health System, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      Minnesota Clinical Research Center, St. Paul,  Minnesota,  55114,  United States
Missouri
      Washington Univ. School of Medicine, St. Louis,  Missouri,  63110,  United States
Nebraska
      Gastroenterology Specialties, PC, Lincoln,  Nebraska,  68503,  United States
New York
      Daniel H. Present, MD, New York,  New York,  10028,  United States
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States
North Carolina
      Univ. of North Carolina Hospital, Chapel Hill,  North Carolina,  27599,  United States
      Duke Health Center, Durham,  North Carolina,  27710,  United States
      Wake Research Associates, LLC, Raleigh,  North Carolina,  27612,  United States
      Charlotte Gastroenterology & Hepatology, PLLC, Charlotte,  North Carolina,  28207,  United States
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
Oklahoma
      Oklahoma Foundation for Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States
      Gastroenterology United of Tulsa, Tulsa,  Oklahoma,  74135,  United States
Oregon
      West Hills Gastroenterology, Portland,  Oregon,  97225,  United States
Pennsylvania
      Hospital of the Univ. of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
Tennessee
      Memphis Gastroenterology Group, PC, Memphis,  Tennessee,  38120,  United States
      Nashville Clinical Research, Nashville,  Tennessee,  37211,  United States
Texas
      Gastroenterology Clinic of San Antonio, San Antonio,  Texas,  78229,  United States
      GANT Research, PA, Fort Worth,  Texas,  76102,  United States
Virginia
      Univ. of Virginia Health System, Charlottesville,  Virginia,  22908,  United States
Wisconsin
      Wisconsin Center for Advanced Research, LLC, Milwaukee,  Wisconsin,  53207,  United States

Study ID Numbers:  OP201
Record last reviewed:  October 2002
Last Updated:  October 13, 2004
Record first received:  April 16, 2002
ClinicalTrials.gov Identifier:  NCT00033943
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08