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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00033943

Enrollment

270

Registered

2002-04-17

Start date

2001-01-31

Completion date

2002-09-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGdeligoparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026