Crohn's DiseasePhase 2NCT01345799
A Study of TRK-170 for the Treatment of Crohn's Disease
A Phase 2 study testing TRK-170 in people with Crohn's Disease, run by Toray Industries, Inc at 13 sites in 13 countries.
Trial summary
In Crohn's Disease Patients To evaluate the efficacy of TRK-170 To evaluate the PK characteristics of TRK-170 To assess the safety of TRK-170 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- TRK-170
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Apr 2011to Apr 2014
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient has a diagnosis of Crohn's Disease before screening
- Patient has stable disease activity
Who cannot join
- Patient has had a clinically significant illness prior to screening
- Patient with clinically significant deviations in laboratory values
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
About this study
Official title: A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
In Crohn's Disease Patients
- To evaluate the efficacy of TRK-170
- To evaluate the PK characteristics of TRK-170
- To assess the safety of TRK-170
- Conditions
- Crohn's Disease
- Being tested
- TRK-170, Placebo
- Keywords
- Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-170Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TRK-170 Low Dose | Experimental | Not described Receives: Drug: TRK-170 |
| TRK-170 Middle Dose | Experimental | Not described Receives: Drug: TRK-170 |
| TRK-170 High Dose | Experimental | Not described Receives: Drug: TRK-170 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index
8 weeks (treatment), 4 weeks (follow-up)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Study completionApr 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345799
- Sponsor's protocol ID
- 170CDT01
- Status last verified
- Jun 2014
- First submitted
- 28 Apr 2011
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
- ClinicalTrials.gov ID
- NCT01345799
- Acronym / sponsor ID
- 170CDT01
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Study completion
- Apr 2014 (actual)
- First posted
- 2 May 2011 (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.
In Crohn's Disease Patients
- To evaluate the efficacy of TRK-170
- To evaluate the PK characteristics of TRK-170
- To assess the safety of TRK-170
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRK-170 Low Dose | Experimental | Drug: TRK-170 |
| TRK-170 Middle Dose | Experimental | Drug: TRK-170 |
| TRK-170 High Dose | Experimental | Drug: TRK-170 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient has a diagnosis of Crohn's Disease before screening
- Patient has stable disease activity
Key exclusion criteria (2 listed)
- Patient has had a clinically significant illness prior to screening
- Patient with clinically significant deviations in laboratory values
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 |
|---|---|---|
| TRK-170 | Drug | TRK-170 High Dose, TRK-170 Low Dose, TRK-170 Middle Dose |
| Placebo | Drug | Placebo |
Primary outcome
Crohn's Disease Activity Index
Time frame: 12 weeks
8 weeks (treatment), 4 weeks (follow-up)
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 12 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRK-170 in people with Crohn's Disease, run by Toray Industries, Inc at 13 sites in 13 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 2 inclusion and 2 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 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Bulgaria, Czechia, France, Hungary and 8 more countries. 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 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?
Crohn's Disease Activity Index (time frame: 12 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 12 Jun 2014.