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

Toray Industries

Status and phase: Completed; Phase 2

Conditions: Post-Herpetic Neuralgia

Treatments: Drug: TRK-700; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02701374

700PNC01

Details and patient eligibility

About

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

Enrollment: 184 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 3 patient groups, including a placebo group

1:TRK-700

Experimental group

Description:

high dose

Treatment:

Drug: TRK-700

2:TRK-700

Experimental group

Description:

low dose

Treatment:

Drug: TRK-700

3:Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo