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

This study has been completed.

Sponsor:

Information provided by:

Incara Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00033943

First received: April 16, 2002

Last updated: June 23, 2005

Last verified: October 2002

History of Changes

Tracking Information
First Received Date ^ICMJE	April 16, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	January 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00033943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Ulcerative Colitis
Intervention ^ICMJE	Drug: deligoparin
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	270
Completion Date	September 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00033943
Other Study ID Numbers ^ICMJE	OP201
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Incara Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Incara Pharmaceuticals
Verification Date	October 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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