Trial record 15 of 202 for:
Open Studies | "Crohn Disease"
A Study of TRK-170 for the Treatment of Crohn's Disease
This study is currently recruiting participants.
Verified November 2012 by Toray Industries, Inc
Sponsor:
Toray Industries, Inc
Information provided by (Responsible Party):
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT01345799
First received: April 28, 2011
Last updated: November 12, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
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)
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2011 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345799
Contacts
| Contact: TRK-170 Team | +81-47-350-6754 | Clinicaltrials-info@nts.toray.co.jp |
Locations
| Belgium | |
| Belgium | Recruiting |
| Belgium, Belgium | |
| Bulgaria | |
| Bulgaria | Recruiting |
| Bulgaria, Bulgaria | |
| Czech Republic | |
| Czech Republic | Recruiting |
| Czech Republic, Czech Republic | |
| France | |
| France | Recruiting |
| France, France | |
| Hungary | |
| Hungary | Recruiting |
| Hungary, Hungary | |
| Latvia | |
| Latvia | Recruiting |
| Latvia, Latvia | |
| Netherlands | |
| The Netherlands | Recruiting |
| The Netherlands, Netherlands | |
| Norway | |
| Norway | Recruiting |
| Norway, Norway | |
| Poland | |
| Poland | Recruiting |
| Poland, Poland | |
| Romania | |
| Romania | Recruiting |
| Romania, Romania | |
| Serbia | |
| Serbia | Recruiting |
| Serbica, Serbia | |
| Sweden | |
| Sweden | Recruiting |
| Sweden, Sweden | |
| Ukraine | |
| Ukraine | Recruiting |
| 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: | November 12, 2012 |
| 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 June 17, 2013