A Study of TRK-170 for the Treatment of Crohn's Disease | NCT01345799

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

NCT01345799

Sponsor

Toray Industries, Inc

Status

Completed

Last Update Posted

Jun 12, 2014Estimated

Enrollment

123Actual

Phase

Phase 2

Conditions

Crohn's Disease

Interventions

TRK-170
Placebo

Countries

Belgium
Bulgaria
Czechia
France
Hungary
Latvia
Netherlands
Norway
Poland
Romania
Serbia
Sweden
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Not provided

Completion Date

Apr 2014Actual

First Submitted Date

Apr 28, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2014

Last Update Posted Date

Jun 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TRK-170 Low Dose	Experimental	Drug: TRK-170
TRK-170 Middle Dose	Experimental	Drug: TRK-170
TRK-170 High Dose	Experimental	Drug: TRK-170
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRK-170	Drug		TRK-170 High Dose TRK-170 Low Dose TRK-170 Middle Dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crohn's Disease Activity Index	8 weeks (treatment), 4 weeks (follow-up)	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Belgium		Belgium			Belgium
Bulgaria