Study for the Treatment of Ulcerative Colitis With Adacolumn
NCT ID: NCT00102193
Last Updated: 2008-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2004-07-31
2006-07-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Adacolumn Apheresis System
Eligibility Criteria
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Inclusion Criteria
* Adequate peripheral venous access to allow for completion of the apheresis treatments
* Receiving one or more of the following medical therapies:
\*sulfasalazine, \*mesalamine and other 5-ASA agents, \*prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response
* Agree to participate in the required follow-up visits
* Able to complete a diary
* Signed written informed consent document and authorization for use of protected health information
Exclusion Criteria
* Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
* Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
* Requiring in-patient hospitalization
* A history of allergic reaction to heparin or heparin-induced thrombocytopenia
* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
* A history of severe cardiovascular or peripheral arterial diseases
* A history of cerebral vascular diseases
* Liver diseases
* Renal insufficiency
* Insulin-dependent Type I or Type II diabetes
* Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
* Any hypercoagulable disorder
* Known infection with Hepatitis B or C, or HIV
* Severe anemia
* Leukopenia or granulocytopenia
* Evidence of current systemic infection
* Malignancy
* Pregnant, lactating or planning to become pregnant during the course of the investigational study
* Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
18 Years
75 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Principal Investigators
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Yosuke Komatsu, MD, PhD
Role: STUDY_DIRECTOR
Otsuka America Pharmaceutical
Locations
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Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Providence Clinical Research
Burbank, California, United States
University of California, San Francisco
San Francisco, California, United States
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago, Department of Medicine, Section of Gastroenterology
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
Massachusetts General Hospital, GI Unit
Boston, Massachusetts, United States
Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
University of North Carolina, Division of Digestive Disease & Nutrition
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Digestive Disease Specialists Inc.
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Gastroenterology and Hepatology Clinic
Abbotsford, British Columbia, Canada
St Paul's Hospital, University of British Columbia
Vancouver, British Columbia, Canada
Hotel-Dieu Hospital
Kingston, Ontario, Canada
London Health Sciences Centre, South Street Campus
London, Ontario, Canada
London Health Sciences Centre, University Campus
London, Ontario, Canada
The Ottawa Hospital-Civic Campus
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Hôtel-Dieu de Lévis
Lévis, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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512-04-205
Identifier Type: -
Identifier Source: org_study_id