Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

Phase 4

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00219414
• Lead Sponsor: Otsuka Frankfurt Research Institute GmbH

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Study Completion: 2006-06
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-26
• Last Update Posted: 2007-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.