We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01345799
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: TRK-170 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2011
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Crohn's Disease Activity Index [ Time Frame: 12 weeks ]
    8 weeks (treatment), 4 weeks (follow-up)


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT01345799     History of Changes
Other Study ID Numbers: 170CDT01
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014

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