AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT00102193

Study for the Treatment of Ulcerative Colitis With Adacolumn

A Phase 3 study testing Adacolumn Apheresis System in people with Ulcerative Colitis, run by Otsuka America Pharmaceutical at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Adacolumn Apheresis System
Type of treatment
Medical device
How many people
168 participants
Where
37 sitesin 2 countries
Study dates
Jul 2004to Jul 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States26 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital, GI Unit

    Boston, Massachusetts, 02114

  • Tufts University School of Medicine, Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Providence Clinical Research

    Burbank, California, 91505

  • University of North Carolina, Division of Digestive Disease & Nutrition

    Chapel Hill, North Carolina, 27599-7080

  • Metropolitan Gastroenterology Group

    Chevy Chase, Maryland, 20815

  • University of Chicago, Department of Medicine, Section of Gastroenterology

    Chicago, Illinois, 60637-1436

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Clinical Research Institute of Michigan

    Clinton Township, Michigan, 48047

  • University of Texas Southern Medical Center

    Dallas, Texas, 75390-9016

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0632

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792-5124

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2285

  • Digestive Disease Specialists Inc.

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic Scottsdale

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, San Francisco

    San Francisco, California, 94143-1623

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Rocky Mountain Gastroenterology Associates, PC

    Wheat Ridge, Colorado, 80033

Other trials in United States

Canada11 sites

  • Gastroenterology and Hepatology Clinic

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Walter Mackenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2C8

  • Hotel-Dieu Hospital

    Kingston, Ontario, K7L 5G2

  • Hôtel-Dieu de Lévis

    Lévis, Quebec, G6V 3W6

  • London Health Sciences Centre, South Street Campus

    London, Ontario, N6A 4G5

  • London Health Sciences Centre, University Campus

    London, Ontario, N6A 5A5

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital-Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • St Paul's Hospital, University of British Columbia

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

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

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.

Read the 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)
Being tested
Adacolumn Apheresis System
Keywords
Ulcerative Colitis, Apheresis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adacolumn Apheresis SystemDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
168 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102193
Sponsor's protocol ID
512-04-205
Status last verified
Apr 2008
First submitted
24 Jan 2005
Last updated
8 Sep 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adacolumn Apheresis System in people with Ulcerative Colitis, run by Otsuka America Pharmaceutical at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00102193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in