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

Toray Industries, Inc184 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Post-Herpetic Neuralgia

Interventions

TRK-700DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

Tokyo

Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: baseline to week 8

Data from ClinicalTrials.gov

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