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

Primary Purpose

Post-Herpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TRK-700
Placebo
Sponsored by
Toray Industries, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Herpetic Neuralgia focused on measuring TRK-700, Post-Herpetic Neuralgia

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokyo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1:TRK-700

2:TRK-700

3:Placebo

Arm Description

high dose

low dose

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 26, 2016
Last Updated
October 24, 2017
Sponsor
Toray Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02701374
Brief Title
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia
Official Title
TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Herpetic Neuralgia
Keywords
TRK-700, Post-Herpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:TRK-700
Arm Type
Experimental
Arm Description
high dose
Arm Title
2:TRK-700
Arm Type
Experimental
Arm Description
low dose
Arm Title
3:Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
TRK-700
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in average Numerical Rating Scale (NRS)
Description
Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo
Time Frame
baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tokyo
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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

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