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

Phase 2

Completed

• Conditions: Post-Herpetic Neuralgia
• Interventions: Drug: Placebo; Drug: TRK-700

• Registration Number: NCT02701374
• Lead Sponsor: Toray Industries, Inc

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3:Placebo	Placebo	Placebo
2:TRK-700	TRK-700	low dose
1:TRK-700	TRK-700	high dose

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tokyo; 🇯🇵 Tokyo, Japan