Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102193
Status:
COMPLETED
Last Update Posted:
2008-09-08
First Post:
2005-01-24
Brief Title:
Study for the Treatment of Ulcerative Colitis With Adacolumn
Sponsor:
Otsuka America Pharmaceutical
Organization:
Otsuka America Pharmaceutical
Study Overview
Official Title:
A Randomized Prospective Double-Blinded Placebo-Controlled Sham-Controlled Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2008-04
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:
The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis
Detailed Description:
Trial Features
Non-drug therapy
Most patients can remain on current treatment regimen including prednisone budesonide and medications such as Asacol mesalamine Pentasa mesalamine Colazal balsalazide disodium and Dipentum olsalazine sodium throughout the study
Components of the Study
Study length is 24 weeks which includes a screening visit ten treatment visits over nine weeks and 4 follow-up appointments
Physical exams laboratory tests and disease assessments conducted at no charge to the patient
21 Randomization treatmentsham
Non-drug therapy
Most patients can remain on current treatment regimen including prednisone budesonide and medications such as Asacol mesalamine Pentasa mesalamine Colazal balsalazide disodium and Dipentum olsalazine sodium throughout the study
Components of the Study
Study length is 24 weeks which includes a screening visit ten treatment visits over nine weeks and 4 follow-up appointments
Physical exams laboratory tests and disease assessments conducted at no charge to the patient
21 Randomization treatmentsham
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