CompletedNCT02701374Updated Oct 25, 2017

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

A Phase 2 interventional study of TRK-700 and Placebo in Post-Herpetic Neuralgia, sponsored by Toray Industries, Inc. Completed at 1 site in Japan. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Toray Industries, Inc · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 184
Allocation: Randomized
Ages: 20 Years to 84 Years
Sex: All

Study 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

Conditions studied

Post-Herpetic Neuralgia

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Keywords

TRK-700
Post-Herpetic Neuralgia

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 184 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Toray Industries, Inc is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 84 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 184 participants (actual)

Study arms

Experimental
1:TRK-700
high dose
Drug: TRK-700
Experimental
2:TRK-700
low dose
Drug: TRK-700
Placebo comparator
3:Placebo
Placebo
Drug: Placebo

Interventions

DrugTRK-700
DrugPlacebo

What researchers measure

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

Study locations

1 site

Tokyo
Tokyo, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02701374
Lead sponsor: Toray Industries, Inc
Responsible party: Sponsor
First posted: Mar 8, 2016
Start date: Mar 2016
Primary completion: Jul 2017
Completion: Jul 2017
Last update: Oct 25, 2017

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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