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

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.

Completed

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Study type

Interventional

Phase

Phase 4

About this study

Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

Adacolumn Apheresis System

Device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Otsuka Frankfurt Research Institute GmbH

Industry

Registry information

Important dates

Study start: 2005
Study completion: 2006
First posted: Sep 22, 2005
Registry last updated: Sep 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed