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OpenTrials
Completed

NCT Number: NCT01345799

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

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

Completed

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRK-170

Drug

Placebo

Drug

Primary outcomes

  1. Crohn's Disease Activity Index

    Time frame: 12 weeks

    8 weeks (treatment), 4 weeks (follow-up)

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Study completion
2014
First posted
May 2, 2011
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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