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A Study of TRK-170 for the Treatment of Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TRK-170
Placebo
Sponsored by
Toray Industries, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Belgium
  • Bulgaria
  • Czech Republic
  • France
  • Hungary
  • Latvia
  • The Netherlands
  • Norway
  • Poland
  • Romania
  • Serbia
  • Sweden
  • Ukraine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TRK-170 Low Dose

TRK-170 Middle Dose

TRK-170 High Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index
8 weeks (treatment), 4 weeks (follow-up)

Secondary Outcome Measures

Full Information

First Posted
April 28, 2011
Last Updated
June 11, 2014
Sponsor
Toray Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01345799
Brief Title
A Study of TRK-170 for the Treatment of Crohn's Disease
Official Title
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease Activity Index, Crohn's Disease, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRK-170 Low Dose
Arm Type
Experimental
Arm Title
TRK-170 Middle Dose
Arm Type
Experimental
Arm Title
TRK-170 High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRK-170
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Description
8 weeks (treatment), 4 weeks (follow-up)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Belgium
City
Belgium
Country
Belgium
Facility Name
Bulgaria
City
Bulgaria
Country
Bulgaria
Facility Name
Czech Republic
City
Czech Republic
Country
Czech Republic
Facility Name
France
City
France
Country
France
Facility Name
Hungary
City
Hungary
Country
Hungary
Facility Name
Latvia
City
Latvia
Country
Latvia
Facility Name
The Netherlands
City
The Netherlands
Country
Netherlands
Facility Name
Norway
City
Norway
Country
Norway
Facility Name
Poland
City
Poland
Country
Poland
Facility Name
Romania
City
Romania
Country
Romania
Facility Name
Serbia
City
Serbica
Country
Serbia
Facility Name
Sweden
City
Sweden
Country
Sweden
Facility Name
Ukraine
City
Ukraine
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

A Study of TRK-170 for the Treatment of Crohn's Disease

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