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

June 23, 2005 updated by: Incara Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

270

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • AGMG Clinical Research
      • Orange, California, United States, 92868
        • Community Clinical Trials
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Rocky Mountain Gastroenterology Associates
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Clinical Research
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Gainesville/Gainesville VAMC
      • Jacksonville, Florida, United States, 32223
        • Borland-Groover Clinic
      • Miami, Florida, United States, 33173
        • Miami Research Associates
      • Miami, Florida, United States, 33136
        • University of Miami, Division of Clinical Pharmacology
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ. of Kentucky Medical Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Minnesota Clinical Research Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington Univ. School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
        • Gastroenterology Specialties, PC
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • New York, New York, United States, 10028
        • Daniel H. Present, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ. of North Carolina Hospital
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Durham, North Carolina, United States, 27710
        • Duke Health Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
      • Tulsa, Oklahoma, United States, 74135
        • Gastroenterology United of Tulsa
    • Oregon
      • Portland, Oregon, United States, 97225
        • West Hills Gastroenterology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the Univ. of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology Group, PC
      • Nashville, Tennessee, United States, 37211
        • Nashville Clinical Research
    • Texas
      • Fort Worth, Texas, United States, 76102
        • GANT Research, PA
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Clinic of San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univ. of Virginia Health System
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53207
        • Wisconsin Center for Advanced Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incara Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

April 16, 2002

First Submitted That Met QC Criteria

April 16, 2002

First Posted (Estimate)

April 17, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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