UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Title of the study (Brief title)	Nalfurafine hydrochloride and chronic liver diseases
Region	Japan

Condition
Condition	Chronic liver disease patients with refractory pruritus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of the current study is to examine the impact of study drug on sleep quality for CLD patients with pruritus usng actigram.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Sleep related variables using actigram
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Study drug (1 cap per day) will be prescribed orally after dinner or before going to bed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with hepatic inflammation persisting for at least 6 months Patients who were not expected to show rapid changes in the general status Patients whose pruritus was regarded as to be uncontrollable by medicines within 6 months before IC.
Key exclusion criteria	(1)Patients with past history for hypersensitivity for the ingredients of testing drugs. (2)Female patients with pregnancy or suspected of being pregnant, or those desiring pregnancy during study period. (3)Lactating female patients (4)Patients who were judged to be inappropriate for the study subjects
Target sample size	50

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo college of medicine
Division name	Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
TEL	0798-45-6111
Email	kantan@hyo-med.ac.jp

Public contact
Name of contact person	kazunori Yoh
Organization	Hyogo college of medicine
Division name	Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
TEL	0798-45-6111
Homepage URL
Email	mm2wintwin@ybb.ne.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 10 Day
Last modified on	2017 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032233