Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
NCT00219414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2007-09-27
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.
Conditions
Interventions
- DEVICE
-
Adacolumn Apheresis System
Sponsors & Collaborators
-
Otsuka Frankfurt Research Institute GmbH
lead INDUSTRY
Principal Investigators
-
Robert Lofberg, Prof. · IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
-
Toshifumi Hibi, Prof. · Keio University, Tokyo, Japan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Completion
- 2006-06-30
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