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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023638
Receipt No. R000027223
Scientific Title Alternate-day oral therapy with Nalfurafine hydrochloride as refractory pruritus for liver cirrhotic patients
Date of disclosure of the study information 2016/08/16
Last modified on 2016/08/16

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Basic information
Public title Alternate-day oral therapy with Nalfurafine hydrochloride
as refractory pruritus for liver cirrhotic patients

Acronym Alternate-day therapy with Nalfurafine hydrochloride
Scientific Title Alternate-day oral therapy with Nalfurafine hydrochloride
as refractory pruritus for liver cirrhotic patients

Scientific Title:Acronym Alternate-day therapy with Nalfurafine hydrochloride
Region
Japan

Condition
Condition Liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the possibility of alternate-day administration of Nalfurafine hydrochloride to liver cirrhosis of Child-Pugh Class B
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the rate of accomplish of alternate-day oral therapy with Nalfurafine hydrochloride
Key secondary outcomes 1)To determine the plasma concentration of Nalfurafine hydrochloride during alternate-day oral therapy
2)To investigate the therapeutic effect according to gene polyrmorphism of OPRM1.

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 Nalfurafine hydrochloride
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
90 years-old >
Gender Male and Female
Key inclusion criteria Intractable pruritus in patients with liver cirrhosis of Child-Pugh class B
Key exclusion criteria Patients who are regarded as inappropriate to participate the study

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironao Okubo
Organization Juntendo University Nerima Hospital
Division name Department of Gastroenterology
Zip code
Address 3-1-10 Takanodai, Nerima-ku Tokyo Japan
TEL 03-5923-3111
Email drokubo@juntendo-nerima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahama
Organization Juntendo University
Division name Center of study driving
Zip code
Address 2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL 03-3813-3176
Homepage URL
Email rinri@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo 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
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 順天堂大学練馬病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 16 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 16 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
2016 Year 08 Month 16 Day
Last modified on
2016 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027223

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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