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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier:
NCT00219414
First received: September 19, 2005
Last updated: September 26, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Device: Adacolumn Apheresis System
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 42
Study Start Date: June 2005
Estimated Study Completion Date: June 2006
Detailed Description:

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

  Eligibility

Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219414

Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Investigators
Principal Investigator: Robert Lofberg, Prof. IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Principal Investigator: Toshifumi Hibi, Prof. Keio University, Tokyo, Japan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00219414     History of Changes
Other Study ID Numbers: 512-04-205-CS
Study First Received: September 19, 2005
Last Updated: September 26, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 29, 2014