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

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ClinicalTrials.gov Identifier: NCT00033943
Recruitment Status : Completed
First Posted : April 17, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Incara Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: deligoparin Phase 2 Phase 3

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  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2001
Study Completion Date : September 2002

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033943


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Sponsors and Collaborators
Incara Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00033943     History of Changes
Other Study ID Numbers: OP201
First Posted: April 17, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2002

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases