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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033943
• Other study ID #: OP201
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 16, 2002
• Last updated: June 23, 2005
• Start date: January 2001
• Est. completion date: September 2002

Study information

• Verified date: October 2002
• Source: Incara Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• deligoparin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Incara Pharmaceuticals

Country where clinical trial is conducted

United States,