A Study of TRK-170 for the Treatment of Crohn's Disease
Sponsor
Toray Industries, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01345799
Collaborator
(none)
123
13
4
36
9.5
0.3
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
Study Start Date
:
Apr 1, 2011
Actual Study Completion Date
:
Apr 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TRK-170 Low Dose
|
Drug: TRK-170
|
| Experimental: TRK-170 Middle Dose
|
Drug: TRK-170
|
| Experimental: TRK-170 High Dose
|
Drug: TRK-170
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Crohn's Disease Activity Index [12 weeks]
8 weeks (treatment), 4 weeks (follow-up)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient has a diagnosis of Crohn's Disease before screening
-
Patient has stable disease activity
Exclusion Criteria:
-
Patient has had a clinically significant illness prior to screening
-
Patient with clinically significant deviations in laboratory values
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Belgium | Belgium | Belgium | ||
| 2 | Bulgaria | Bulgaria | Bulgaria | ||
| 3 | Czech Republic | Czech Republic | Czech Republic | ||
| 4 | France | France | France | ||
| 5 | Hungary | Hungary | Hungary | ||
| 6 | Latvia | Latvia | Latvia | ||
| 7 | The Netherlands | The Netherlands | Netherlands | ||
| 8 | Norway | Norway | Norway | ||
| 9 | Poland | Poland | Poland | ||
| 10 | Romania | Romania | Romania | ||
| 11 | Serbia | Serbica | Serbia | ||
| 12 | Sweden | Sweden | Sweden | ||
| 13 | Ukraine | Ukraine | Ukraine |
Sponsors and Collaborators
- Toray Industries, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT01345799
Other Study ID Numbers:
- 170CDT01
First Posted:
May 2, 2011
Last Update Posted:
Jun 12, 2014
Last Verified:
Jun 1, 2014
Keywords provided by Toray Industries, Inc
Additional relevant MeSH terms: