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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT01345799
First received: April 28, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Crohn's Disease
Drug: TRK-170
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Toray Industries, Inc:

Primary Outcome Measures:
  • Crohn's Disease Activity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    8 weeks (treatment), 4 weeks (follow-up)


Enrollment: 123
Study Start Date: April 2011
Study Completion Date: April 2014
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345799

Locations
Belgium
Belgium
Belgium, Belgium
Bulgaria
Bulgaria
Bulgaria, Bulgaria
Czech Republic
Czech Republic
Czech Republic, Czech Republic
France
France
France, France
Hungary
Hungary
Hungary, Hungary
Latvia
Latvia
Latvia, Latvia
Netherlands
The Netherlands
The Netherlands, Netherlands
Norway
Norway
Norway, Norway
Poland
Poland
Poland, Poland
Romania
Romania
Romania, Romania
Serbia
Serbia
Serbica, Serbia
Sweden
Sweden
Sweden, Sweden
Ukraine
Ukraine
Ukraine, Ukraine
Sponsors and Collaborators
Toray Industries, Inc
  More Information

No publications provided

Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT01345799     History of Changes
Other Study ID Numbers: 170CDT01
Study First Received: April 28, 2011
Last Updated: June 11, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Conseil National de l'Ordre des Médecins
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Serbia : Agency for Medicines and Medical Devices Agency of Serbia
Latvia: State Agency of Medicines
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Ukraine: Ministry of Health

Keywords provided by Toray Industries, Inc:
Crohn's Disease Activity Index
Crohn's Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 21, 2014