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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Device: Adacolumn Apheresis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219414

512-04-205-CS

Details and patient eligibility

About

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.

Full description

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

Sex

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind