UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028161
Receipt number 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 08:18:01

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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 or person

Institute

Hyogo college of medicine

Institute

Department

Personal name



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

Value
https://center6.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