Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162942
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2005-09-09
Brief Title:
Study for the Treatment of Crohns Disease 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 Crohns Disease
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohns disease
Detailed Description:
Trial Features
Medical device Non-drug option
Most patients can remain on current treatment regimen 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
Open-Label extension offered to eligible patients
Medical device Non-drug option
Most patients can remain on current treatment regimen 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
Open-Label extension offered to eligible patients
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