臨床研究等提出・公開システム

Date of registration	June. 05, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222514

Scientific Title	A General Clinical Pharmacological Study of TRK-820 Soft Capsules - Refractory Pruritus in Patients on Peritoneal Dialysis-
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Toray Industries,Inc.
	Address	Clinicaltrials-info@nts.toray.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Open-label study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients on Peritoneal Dialysis (2)It can be confirmed that the treatment of pruritus with existing therapies such as antihistamines or antiallergics has not been adequately effective in such patients
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Intractable Pruritus in Patients on Peritoneal Dialysis
Intervention(s)		investigational material(s) Generic name etc : TRK-820 INN of investigational material : Nalfurafine Hydrochloride Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : TRK-820 Soft Capsules are to be administered orally once daily after supper for 28 days. 2.5 microg of TRK-820 is to be administered daily on the 1st, and 2nd weeks and 5 microg of TRK-820 is to be administered daily on the 3rd, and 4th weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Changes in the VAS values
Secondary Outcome		Changes in the VAS values, Changes in the itching scores, Mean VAS values, Mean itching scores, VAS improvement degree

Primary Sponsor	Toray Industries,Inc.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142565
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Aug. 24, 2015	Detail	Changes
6	Aug. 24, 2015	Detail	Changes
5	June. 10, 2015	Detail	Changes
4	July. 31, 2014	Detail	Changes
3	July. 31, 2014	Detail	Changes
2	June. 16, 2014	Detail	Changes
1	June. 05, 2014	Detail

List of change history