Back to resultsStudy for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Adacolumn Apheresis System
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.
Secondary Outcome Measures
Full Information
NCT ID
NCT00219414
First Posted
September 19, 2005
Last Updated
September 26, 2007
Sponsor
Otsuka Frankfurt Research Institute GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00219414
Brief Title
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Frankfurt Research Institute GmbH
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.
Detailed Description
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Adacolumn Apheresis System
Primary Outcome Measure Information:
Title
Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.
10. Eligibility
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lofberg, Prof.
Organizational Affiliation
IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, Prof.
Organizational Affiliation
Keio University, Tokyo, Japan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
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