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Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
This study has been completed.
First Received: April 16, 2002   Last Updated: June 23, 2005   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Incara Pharmaceuticals:

Estimated Enrollment: 270
Study Start Date: January 2001
Estimated Study Completion Date: September 2002
Detailed Description:

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033943

  Hide Study Locations
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
Sponsors and Collaborators
Incara Pharmaceuticals
  More Information

No publications provided

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

Additional relevant MeSH terms:
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on November 25, 2009