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Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

NCT ID: NCT00033943

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-09-30

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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deligoparin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incara Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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AGMG Clinical Research

Anaheim, California, United States

Site Status

Community Clinical Trials

Orange, California, United States

Site Status

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, United States

Site Status

Rocky Mountain Clinical Research

Littleton, Colorado, United States

Site Status

University of Florida Gainesville/Gainesville VAMC

Gainesville, Florida, United States

Site Status

Borland-Groover Clinic

Jacksonville, Florida, United States

Site Status

University of Miami, Division of Clinical Pharmacology

Miami, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, United States

Site Status

Univ. of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Metropolitan Gastroenterology Group

Chevy Chase, Maryland, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Minnesota Clinical Research Center

Saint Paul, Minnesota, United States

Site Status

Washington Univ. School of Medicine

St Louis, Missouri, United States

Site Status

Gastroenterology Specialties, PC

Lincoln, Nebraska, United States

Site Status

Long Island Clinical Research Associates

Great Neck, New York, United States

Site Status

Daniel H. Present, MD

New York, New York, United States

Site Status

Univ. of North Carolina Hospital

Chapel Hill, North Carolina, United States

Site Status

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, United States

Site Status

Duke Health Center

Durham, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Consultants for Clinical Research

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

Gastroenterology United of Tulsa

Tulsa, Oklahoma, United States

Site Status

West Hills Gastroenterology

Portland, Oregon, United States

Site Status

Hospital of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Memphis Gastroenterology Group, PC

Memphis, Tennessee, United States

Site Status

Nashville Clinical Research

Nashville, Tennessee, United States

Site Status

GANT Research, PA

Fort Worth, Texas, United States

Site Status

Gastroenterology Clinic of San Antonio

San Antonio, Texas, United States

Site Status

Univ. of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Wisconsin Center for Advanced Research, LLC

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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OP201

Identifier Type: -

Identifier Source: org_study_id