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NCT01345799 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01345799
Other study ID # 170CDT01
Secondary ID
Status Completed
Phase Phase 2
First received April 28, 2011
Last updated June 11, 2014
Start date April 2011
Est. completion date April 2014

Study information
Verified date June 2014
Source Toray Industries, Inc
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Conseil National de l'Ordre des MédecinsNorway: Norwegian Medicines AgencySweden: Medical Products AgencySerbia : Agency for Medicines and Medical Devices Agency of SerbiaLatvia: State Agency of MedicinesBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesUkraine: Ministry of Health
Study type Interventional

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date April 2014
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TRK-170

• Placebo

Locations
Country Name City State
Belgium Belgium Belgium
Bulgaria Bulgaria Bulgaria
Czech Republic Czech Republic Czech Republic
France France France
Hungary Hungary Hungary
Latvia Latvia Latvia
Netherlands The Netherlands The Netherlands
Norway Norway Norway
Poland Poland Poland
Romania Romania Romania
Serbia Serbia Serbica
Sweden Sweden Sweden
Ukraine Ukraine Ukraine

Sponsors (1)
Lead Sponsor Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Crohn's Disease Activity Index 8 weeks (treatment), 4 weeks (follow-up) 12 weeks Yes
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