NCT02701374

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

February 26, 2016

Last Update Submit

October 24, 2017

Conditions

Post-Herpetic Neuralgia

Keywords

TRK-700Post-Herpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

1:TRK-700

EXPERIMENTAL

high dose

Drug: TRK-700

2:TRK-700

EXPERIMENTAL

low dose

Drug: TRK-700

3:Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TRK-700DRUG
1:TRK-7002:TRK-700
PlaceboDRUG
3:Placebo

Eligibility Criteria

Age20 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo

Tokyo, Japan

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 8, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

JP(1)