A Study of TRK-170 for the Treatment of Crohn's Disease
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
1 other identifier
interventional
123
12 countries
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 12, 2014
June 1, 2014
April 28, 2011
June 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Crohn's Disease Activity Index
8 weeks (treatment), 4 weeks (follow-up)
12 weeks
Study Arms (4)
TRK-170 Low Dose
EXPERIMENTALTRK-170 Middle Dose
EXPERIMENTALTRK-170 High Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient has a diagnosis of Crohn's Disease before screening
- Patient has stable disease activity
You may not qualify if:
- Patient has had a clinically significant illness prior to screening
- Patient with clinically significant deviations in laboratory values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Belgium
Belgium, Belgium
Bulgaria
Bulgaria, Bulgaria
Czech Republic
Czech Republic, Czechia
France
France, France
Hungary
Hungary, Hungary
Latvia
Latvia, Latvia
The Netherlands
The Netherlands, Netherlands
Norway
Norway, Norway
Poland
Poland, Poland
Romania
Romania, Romania
Serbia
Serbica, Serbia
Sweden
Sweden, Sweden
Ukraine
Ukraine, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 2, 2011
Study Start
April 1, 2011
Study Completion
April 1, 2014
Last Updated
June 12, 2014
Record last verified: 2014-06