UMIN-CTR Clinical Trial

Basic information
Public title	Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Acronym	Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Scientific Title	Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Scientific Title:Acronym	Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Region	Japan

Condition
Condition	Pruritus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare with efficacy of nalfurafine hydrochloride and fexofenadine hydrochloride in obstructive jaundice patients with pruritus and chronic hepatitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare with curative effect for pruritus in 2 weeks later medicating between "nalfurafine hydrochloride group" and "fexofenadine hydrochloride group".
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	nalfuraine hydrochloride group
Interventions/Control_2	fexofenadine hydrochloride group
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	Obstructive jaundice patients with hyperbilirubinemia (serum bilirubin levels are over 3mg/dL). Chronic hepatitis patients diagnosed with blood test and/or imaging examination. Patients have itchiness. Informed consent must be obtained from patients themselves.
Key exclusion criteria	Patient's consciousness are not alert. Presence of hypersensitivity to nalfurafine hydrochloride and/or fexofenadine hydrochloride. Presence of other dermatosis except for jaundice associated pruritis. Presence of sever organopathy and/or drug allergy. Patients who pregnant or possibility of pregnant, lactating and desire for childbearing. Difficult to ingestion. Ineligible cases are judged by researchers.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Kitano
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Zip code	6410012
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL	+81734472300
Email	kitano@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Shimizu
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Zip code	6410012
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL	+81734472300
Homepage URL
Email	rshimizu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Reserch Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel	+81734472300
Email	wa-rinri@wakayama-med.ac.jp

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	2018 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 27 Day
Date of IRB	2018 Year 07 Month 17 Day
Anticipated trial start date	2018 Year 07 Month 18 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 03 Day
Last modified on	2021 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037908