UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-Institutional Joint Research of Health-Related Quality of Life of Patients with Pruritus due to Chronic Liver Disease
Title of the study (Brief title)	HRQoL of Patients with Pruritus due to Chronic Liver Disease
Region	Japan

Condition
Condition	Chronic Liver Disease, Pruritus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of nalfurafine hydrochloride on pruritus in patients with chronic liver disease will be assessed by SF-36.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	SF-36 score before the therapy: once between -9w and -1W after the start of therapy: every outpatient visit between 0w and 9w once per 9 weeks between 10w and 54w
Key secondary outcomes	VAS scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nalfurafine Hydrochloride 2.5microgram 1cap per day The dose may be increased up to 5.0microgram per day depending on the symptom. Follow-up to 54 weeks
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with therapy-resistant pruritus due to chronic liver disease
Key exclusion criteria	Patients with a history of allergy to the ingredients in Nalfurafine Hydrochloride
Target sample size	150

Research contact person
Name of lead principal investigator	Satoshi Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	049-276-1111
Email	alfsg@saitama-med.ac.jp

Public contact
Name of contact person	Nobuaki Nakayama
Organization	Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	049-276-1111
Homepage URL
Email	alfsg@saitama-med.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
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	埼玉医科大学病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 02 Day
Anticipated trial start date	2016 Year 05 Month 09 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	2016 Year 05 Month 09 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025634