UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023638 |
|---|---|
| Receipt number | 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 | 2022/02/19 17:06:45 |
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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
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
rinri@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027223
