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

Post-Herpetic Neuralgia Clinical Trial

Official title:

TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia —Double Blind Comparison With Placebo—

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701374
• Other study ID #: 700PNC01
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2016
• Last updated: October 24, 2017
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Post-Herpetic Neuralgia

Intervention

Drug:
• TRK-700

• Placebo

Locations

Country	Name	City	State
Japan	Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline to week 8