Crohn's DiseasePhase 2NCT00417391
Phase II Study of RR110 in Patients With Active Crohn's Disease
A Phase 2 study testing RR110 (Tamibarotene) in people with Crohn's Disease, run by R&R Inc. at 8 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- RR110 (Tamibarotene)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesJapan
- Study dates
- Dec 2006to May 2008
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CDAI score ranging from 220 to 450
- Patients with CRP > 1 mg/dL
- Patients who can be hospitalized at least 2 weeks after first administration
Who cannot join
- Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
- Patients who have had surgical bowel resections within 4 weeks of screening
- Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Fujisawa, Kanagawa
Study site
Nakagami, Okinawa
Study site
Nishinomiya, Hyōgo
Study site
Ōtsu, Shiga
Study site
Sakura, Chiba
Study site
Sapporo, Hokkaido
Study site
Shinjuku, Tokyo
Study site
Toyohashi, Aichi-ken
About this study
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- RR110 (Tamibarotene)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR110 (Tamibarotene)Drug
Also called Tamibarotene, Am80
1 mg RR110
RR110 (Tamibarotene)Drug
Also called Tamibarotene, Am80
4 mg RR110
| Study group | Role | What they receive |
|---|---|---|
| 1 mg RR110 | Experimental | 1 mg RR110 Receives: Drug: RR110 (Tamibarotene) |
| 4 mg RR110 | Experimental | 4 mg RR110 Receives: Drug: RR110 (Tamibarotene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Crohn's disease active index (CDAI) score
Measured: 8 weeks
Secondary outcomes (4)
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Measured: 8 weeks
Rate of clinical remission as defined by CDAI < 150
Measured: 8 weeks
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Measured: 10 weeks
Safety parameters
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R&R Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Toshifumi Hibi, M.D., Ph.D., Study chair, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417391
- Sponsor's protocol ID
- 1101-01
- Status last verified
- May 2008
- First submitted
- 28 Dec 2006
- Last updated
- 29 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of RR110 in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00417391
- Acronym / sponsor ID
- 1101-01
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- R&R Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 1 Jan 2007 (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 this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mg RR110 | Experimental | Drug: RR110 (Tamibarotene)1 mg RR110 |
| 4 mg RR110 | Experimental | Drug: RR110 (Tamibarotene)4 mg RR110 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CDAI score ranging from 220 to 450
- Patients with CRP > 1 mg/dL
- Patients who can be hospitalized at least 2 weeks after first administration
Key exclusion criteria (3 listed)
- Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
- Patients who have had surgical bowel resections within 4 weeks of screening
- Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening
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 |
|---|---|---|
| RR110 (Tamibarotene)Also: Tamibarotene, Am801 mg RR110 | Drug | 1 mg RR110 |
| RR110 (Tamibarotene)Also: Tamibarotene, Am804 mg RR110 | Drug | 4 mg RR110 |
Primary outcome
Change in Crohn's disease active index (CDAI) score
Time frame: 8 weeks
4 secondary outcomes
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Time frame: 8 weeks
Rate of clinical remission as defined by CDAI < 150
Time frame: 8 weeks
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Time frame: 10 weeks
Safety parameters
Time frame: 10 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 29 May 2008.
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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.
Toshifumi Hibi, M.D., Ph.D. study chair
Keio University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RR110 (Tamibarotene) in people with Crohn's Disease, run by R&R Inc. at 8 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 3 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 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Crohn's disease active index (CDAI) score (time frame: 8 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 29 May 2008.