NCT00102193

Study for the Treatment of Ulcerative Colitis With Adacolumn

A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (planned)
• Sponsor: Otsuka America Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Adacolumn Apheresis System

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-01-25
• Last updated: 2008-09-08

Locations

37 sites across 2 countries: United States, Canada