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

June 11, 2014 updated by: Toray Industries, Inc

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: TRK-170 Low Dose
Drug: TRK-170
Experimental: TRK-170 Middle Dose
Drug: TRK-170
Experimental: TRK-170 High Dose
Drug: TRK-170

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crohn's Disease Activity Index
Time Frame: 12 weeks
8 weeks (treatment), 4 weeks (follow-up)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toray Industries, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170CDT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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