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

NCT ID: NCT02701374

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Post-Herpetic Neuralgia

Keywords

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TRK-700 Post-Herpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1:TRK-700

high dose

Group Type EXPERIMENTAL

TRK-700

Intervention Type DRUG

2:TRK-700

low dose

Group Type EXPERIMENTAL

TRK-700

Intervention Type DRUG

3:Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TRK-700

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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700PNC01

Identifier Type: -

Identifier Source: org_study_id