Study for the Treatment of Ulcerative Colitis With Adacolumn

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Clinical Trial Description

Trial Features:

- Non-drug therapy

- Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) throughout the study

Components of the Study:

- Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments

- Physical exams, laboratory tests and disease assessments conducted at no charge to the patient

- 2:1 Randomization (treatment:sham) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00102193
Study type	Interventional
Source	Otsuka America Pharmaceutical
Contact
Status	Completed
Phase	Phase 3
Start date	July 2004
Completion date	July 2006

View Details

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