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Sponsored by: |
Otsuka Frankfurt Research Institute GmbH |
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Information provided by: | Otsuka Frankfurt Research Institute GmbH |
ClinicalTrials.gov Identifier: | NCT00366925 |
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.
Condition | Intervention |
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Ulcerative Colitis |
Device: Adacolumn® |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Parallel Assignment |
Official Title: | Randomized Controlled Multicenter Investigation to Compare the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes/Macrophage Apheresis Device, 5 Versus 10 Treatments, in Patients With Active Ulcerative Colitis |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
Receiving one or more of the following medical therapies:
Have not received the above medical therapies due to intolerance or demonstrated non-response for the time periods specified below:
Exclusion Criteria:
Infection:
Germany, Hessen | |
Markus-Krankenhaus | |
Frankfurt am Main, Hessen, Germany, 60431 |
Principal Investigator: | Axel Dignass, Prof. Dr. med. | Markus-Krankenhaus, Frankfurt am Main |
Study ID Numbers: | Ada-UC-05-102 |
Study First Received: | August 21, 2006 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00366925 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |