Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia

October 24, 2017 updated by: Toray Industries, Inc

TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-

In Post-Herpetic Neuralgia(PHN) patients:

  • To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
  • To measure the plasma concentration of TRK-700 and its metabolites

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with pain persisting for at least 3 months after the onset of herpes zoster
  • Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4

Exclusion Criteria:

  • Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
  • Patients with pain other than PHN that may affect the evaluation of pain
  • Patients with pain that is suspected to be mainly psychogenic
  • Patients who have received neurolytic or neurosurgical therapy for PHN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1:TRK-700
high dose
Drug: TRK-700
Experimental: 2:TRK-700
low dose
Drug: TRK-700
Placebo Comparator: 3:Placebo
Placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in average Numerical Rating Scale (NRS)
Time Frame: baseline to week 8
Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo
baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toray Industries, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 700PNC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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