Efficacy and Safety of TRK-700 in Patient With Post-Herpe... | NCT02701374

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

NCT02701374

Sponsor

Toray Industries, Inc

Status

Completed

Last Update Posted

Oct 25, 2017Actual

Enrollment

184Actual

Phase

Phase 2

Conditions

Post-Herpetic Neuralgia

Interventions

TRK-700
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Feb 26, 2016

First Submission Date that Met QC Criteria

Mar 2, 2016

First Posted Date

Mar 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2017

Last Update Posted Date

Oct 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TRK-700	Drug		1:TRK-700 2:TRK-700
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051474	Neuralgia, Postherpetic

Ancestor Terms

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided