Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033943
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-04-16
Brief Title:
Safety and Efficacy of OP2000 Deligoparin in the Treatment of Active Ulcerative Colitis
Sponsor:
Incara Pharmaceuticals
Organization:
Incara Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None