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

NCT ID: NCT01345799

Last Updated: 2014-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TRK-170 Low Dose

Group Type EXPERIMENTAL

TRK-170

Intervention Type DRUG

TRK-170 Middle Dose

Group Type EXPERIMENTAL

TRK-170

Intervention Type DRUG

TRK-170 High Dose

Group Type EXPERIMENTAL

TRK-170

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TRK-170

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Belgium

Belgium, , Belgium

Site Status

Bulgaria

Bulgaria, , Bulgaria

Site Status

Czech Republic

Czech Republic, , Czechia

Site Status

France

France, , France

Site Status

Hungary

Hungary, , Hungary

Site Status

Latvia

Latvia, , Latvia

Site Status

The Netherlands

The Netherlands, , Netherlands

Site Status

Norway

Norway, , Norway

Site Status

Poland

Poland, , Poland

Site Status

Romania

Romania, , Romania

Site Status

Serbia

Serbica, , Serbia

Site Status

Sweden

Sweden, , Sweden

Site Status

Ukraine

Ukraine, , Ukraine

Site Status

Countries

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Belgium Bulgaria Czechia France Hungary Latvia Netherlands Norway Poland Romania Serbia Sweden Ukraine

Other Identifiers

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170CDT01

Identifier Type: -

Identifier Source: org_study_id

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