Ulcerative ColitisPhase 3NCT00347048
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
A Phase 3 study testing tacrolimus in people with Ulcerative Colitis, run by Astellas Pharma Inc at 6 sites in Japan.
Trial summary
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 6 sitesJapan
- Study dates
- Sep 2006to Apr 2008
- 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 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to severe refractory UC patients
- Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
- Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction
Who cannot join
- Mild or fulminant type
- Renal failure patients, hepatic failure patients
- Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
- Patients who received LCAP or GCAP within 2 weeks prior to entry
- Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
- Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shin'etsu Region
About this study
Official title: Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
- Conditions
- Ulcerative Colitis
- Being tested
- tacrolimus, Placebo
- Keywords
- Ulcerative colitis, tacrolimus, FK506, treatment outcome
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called FK506, Prograf
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tacrolimus |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Disease activity index score (DAI score)
Measured: 2 Weeks
Secondary outcomes (5)
Changes of DAI score ( Total & each item)
Measured: 2 Weeks
Changes of clinical severity and symptom
Measured: 2 Weeks
Endoscopic finding
Measured: 2 Weeks
Patients impression
Measured: 2 Weeks
Amount of steroid
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347048
- Sponsor's protocol ID
- F506-CL-1107
- Status last verified
- Aug 2014
- First submitted
- 30 Jun 2006
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT00347048
- Acronym / sponsor ID
- F506-CL-1107
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, tacrolimus, FK506, treatment outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Jul 2006 (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.
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Moderate to severe refractory UC patients
- Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
- Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction
Key exclusion criteria (6 listed)
- Mild or fulminant type
- Renal failure patients, hepatic failure patients
- Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
- Patients who received LCAP or GCAP within 2 weeks prior to entry
- Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
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 |
|---|---|---|
| tacrolimusAlso: FK506, Prograforal | Drug | 1 |
| Placebooral | Drug | 2 |
Primary outcome
Improvement of Disease activity index score (DAI score)
Time frame: 2 Weeks
5 secondary outcomes
Changes of DAI score ( Total & each item)
Time frame: 2 Weeks
Changes of clinical severity and symptom
Time frame: 2 Weeks
Endoscopic finding
Time frame: 2 Weeks
Patients impression
Time frame: 2 Weeks
Amount of steroid
Time frame: 2 Weeks
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 26 Aug 2014.
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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.
Use Central Contact study chair
Astellas Pharma Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus in people with Ulcerative Colitis, run by Astellas Pharma Inc at 6 sites in Japan.
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 3 inclusion and 6 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 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
Improvement of Disease activity index score (DAI score) (time frame: 2 Weeks). 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 26 Aug 2014.