Ulcerative ColitisPhase 4NCT00219414
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
A Phase 4 study testing Adacolumn Apheresis System in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Adacolumn Apheresis System
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2006
- Phase
- Phase 4
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
About this study
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.
Read the detailed description
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
- Conditions
- Ulcerative Colitis
- Being tested
- Adacolumn Apheresis System
- 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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Lofberg, Prof., Principal investigator, IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, SwedenToshifumi Hibi, Prof., Principal investigator, Keio University, Tokyo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219414
- Sponsor's protocol ID
- 512-04-205-CS
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2005
- Last updated
- 27 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
- ClinicalTrials.gov ID
- NCT00219414
- Acronym / sponsor ID
- 512-04-205-CS
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jun 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adacolumn Apheresis System | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Lofberg, Prof. principal investigator
IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Toshifumi Hibi, Prof. principal investigator
Keio University, Tokyo, Japan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adacolumn Apheresis System in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2007.