Clinical Trials Logo
  1. Home
  2. Crohn's Disease
  3. NCT01345799
  4. Details
NCT01345799 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01345799
Other study ID # 170CDT01
Secondary ID
Status Completed
Phase Phase 2
First received April 28, 2011
Last updated June 11, 2014
Start date April 2011
Est. completion date April 2014

Study information
Verified date June 2014
Source Toray Industries, Inc
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Conseil National de l'Ordre des MédecinsNorway: Norwegian Medicines AgencySweden: Medical Products AgencySerbia : Agency for Medicines and Medical Devices Agency of SerbiaLatvia: State Agency of MedicinesBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Agency for Medicines and Medical DevicesUkraine: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date April 2014
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TRK-170

• Placebo

Locations
Country Name City State
Belgium Belgium Belgium
Bulgaria Bulgaria Bulgaria
Czech Republic Czech Republic Czech Republic
France France France
Hungary Hungary Hungary
Latvia Latvia Latvia
Netherlands The Netherlands The Netherlands
Norway Norway Norway
Poland Poland Poland
Romania Romania Romania
Serbia Serbia Serbica
Sweden Sweden Sweden
Ukraine Ukraine Ukraine

Sponsors (1)
Lead Sponsor Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Crohn's Disease Activity Index 8 weeks (treatment), 4 weeks (follow-up) 12 weeks Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3