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OpenTrials
Completed

NCT Number: NCT02701374

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

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

Completed

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Key information

Conditions

Post-herpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRK-700

Drug

Placebo

Drug

Primary outcomes

  1. Change in average Numerical Rating Scale (NRS)

    Time frame: baseline to week 8

    Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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