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

Patrocinadores

Patrocinador principal: Incara Pharmaceuticals

Fuente Incara Pharmaceuticals
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 2001
Fecha de Terminación September 2002
Fase Phase 2/Phase 3
Tipo de estudio Interventional
Inscripción 270
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: deligoparin

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Ubicación
Instalaciones:
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 | St. 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
Ubicacion Paises

United States

Fecha de verificación

October 2002

Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov