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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028161
Receipt No. R000032233
Scientific Title Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Date of disclosure of the study information 2017/07/12
Last modified on 2017/07/12

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Basic information
Public title Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Acronym Nalfurafine hydrochloride and chronic liver diseases
Scientific Title Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo college of medicine
Division name Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name kazunori Yoh
Organization Hyogo college of medicine
Division name Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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