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Study for the Treatment of Ulcerative Colitis With Adacolumn

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ClinicalTrials.gov Identifier: NCT00102193
Recruitment Status : Completed
First Posted : January 25, 2005
Last Update Posted : September 8, 2008
Sponsor:
Information provided by:
Otsuka America Pharmaceutical

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Adacolumn Apheresis System Phase 3

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)

Study Type : Interventional  (Clinical Trial)
Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score
  2. Safety will be evaluated by determining the frequency and severity of adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
  • 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

Key Exclusion Criteria:

  • Evidence of toxic megacolon
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102193


  Show 37 Study Locations
Sponsors and Collaborators
Otsuka America Pharmaceutical
Investigators
Study Director: Yosuke Komatsu, MD, PhD Otsuka America Pharmaceutical

Additional Information:
ClinicalTrials.gov Identifier: NCT00102193     History of Changes
Other Study ID Numbers: 512-04-205
First Posted: January 25, 2005    Key Record Dates
Last Update Posted: September 8, 2008
Last Verified: April 2008

Keywords provided by Otsuka America Pharmaceutical:
Ulcerative Colitis, Apheresis

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