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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01345799
• Date of registration: 28/04/2011
• Prospective Registration: No
• Primary sponsor: Toray Industries, Inc
• Public title: A Study of TRK-170 for the Treatment of Crohn's Disease
• Scientific title: A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
• Date of first enrolment: April 2011
• Target sample size: 123
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01345799
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Placebo

Drug: TRK-170

Primary Outcome(s)

Crohn's Disease Activity Index [Time Frame: 12 weeks]

Secondary ID(s)

170CDT01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors