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Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis Clinical research trials and Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis. Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis  Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis
Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis
For Condition: Ulcerative Colitis
Status: Completed
Sponsor(s): Incara Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 270
Location and Contact Information:
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
United States
AGMG Clinical Research
Anaheim, California, 92801
United States
Miami Research Associates
Miami, Florida, 33173
United States
University of Miami, Division of Clinical Pharmacology
Miami, Florida, 33136
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Rocky Mountain Clinical Research
Littleton, Colorado, 80120
United States
Rocky Mountain Gastroenterology Associates
Lakewood, Colorado, 80215
United States
Memphis Gastroenterology Group, PC
Memphis, Tennessee, 38120
United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219
United States
Univ. of Virginia Health System
Charlottesville, Virginia, 22908
United States
West Hills Gastroenterology
Portland, Oregon, 97225
United States
Hospital of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Nashville Clinical Research
Nashville, Tennessee, 37211
United States
Borland-Groover Clinic
Jacksonville, Florida, 32223
United States
Community Clinical Trials
Orange, California, 92868
United States
Duke Health Center
Durham, North Carolina, 27710
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Florida Gainesville/Gainesville VAMC
Gainesville, Florida, 32608
United States
Minnesota Clinical Research Center
St. Paul, Minnesota, 55114
United States
Long Island Clinical Research Associates
Great Neck, New York, 11021
United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342
United States
Daniel H. Present, MD
New York City, New York, 10028
United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
United States
Gastroenterology Specialties, PC
Lincoln, Nebraska, 68503
United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
United States
Univ. of Kentucky Medical Center
Lexington, Kentucky, 40536
United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229
United States
Wisconsin Center for Advanced Research, LLC
Milwaukee, Wisconsin, 53207
United States
Univ. of North Carolina Hospital
Chapel Hill, North Carolina, 27599
United States
Washington Univ. School of Medicine
St. Louis, Missouri, 63110
United States
GANT Research, PA
Ft. Worth, Texas, 76102
United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135
United States
Additional Information:
Study ID Numbers: OP201;
Study Start Date: January 2001
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033943
Other Ulcerative Colitis Studies:
1. Humanized anti-IL-2 receptor monoclonal antibody in moderate-to-severe ulcerative colitis
2. Study of Infliximab for the treatment of patients with active Ulcerative Colitis.
3. Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis
4. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
5. Left-Sided Ulcerative Colitis Study
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Virginia Clinical Trials
Other Charlottesville Clinical Trials
Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis
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