Clinical trial NCT00033943: Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Incara Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-04-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: AGMG Clinical Research
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Clinical Research
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Gainesville/Gainesville VAMC
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami, Division of Clinical Pharmacology
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Lexington
country: United States
facility: Univ. of Kentucky Medical Center
state: Kentucky
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: St. Paul
country: United States
facility: Minnesota Clinical Research Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington Univ. School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Gastroenterology Specialties, PC
state: Nebraska
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Daniel H. Present, MD
state: New York
city: Chapel Hill
country: United States
facility: Univ. of North Carolina Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Durham
country: United States
facility: Duke Health Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Portland
country: United States
facility: West Hills Gastroenterology
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the Univ. of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Clinical Research
state: Tennessee
city: Fort Worth
country: United States
facility: GANT Research, PA
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic of San Antonio
state: Texas
city: Charlottesville
country: United States
facility: Univ. of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research, LLC
state: Wisconsin
Study officials:
References: