Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
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
1 other identifier
interventional
270
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2001
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 16, 2002
CompletedFirst Posted
Study publicly available on registry
April 17, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedJune 24, 2005
October 1, 2002
April 16, 2002
June 23, 2005
Conditions
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
AGMG Clinical Research
Anaheim, California, 92801, United States
Community Clinical Trials
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 16, 2002
First Posted
April 17, 2002
Study Start
January 1, 2001
Study Completion
September 1, 2002
Last Updated
June 24, 2005
Record last verified: 2002-10