UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022255 |
|---|---|
| Receipt number | R000025634 |
| Scientific Title | Multi-Institutional Joint Research of Health-Related Quality of Life of Patients with Pruritus due to Chronic Liver Disease |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2018/09/21 09:50:42 |
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Basic information
Public title
Multi-Institutional Joint Research of Health-Related Quality of Life of Patients with Pruritus due to Chronic Liver Disease
Acronym
HRQoL of Patients with Pruritus due to Chronic Liver Disease
Scientific Title
Multi-Institutional Joint Research of Health-Related Quality of Life of Patients with Pruritus due to Chronic Liver Disease
Scientific Title:Acronym
HRQoL of Patients with Pruritus due to Chronic Liver Disease
Region
| Japan |
Condition
Condition
Chronic Liver Disease, Pruritus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of nalfurafine hydrochloride on pruritus in patients with chronic liver disease will be assessed by SF-36.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SF-36 score
before the therapy: once between -9w and -1W
after the start of therapy:
every outpatient visit between 0w and 9w
once per 9 weeks between 10w and 54w
Key secondary outcomes
VAS scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nalfurafine Hydrochloride 2.5microgram 1cap per day
The dose may be increased up to 5.0microgram per day depending on the symptom.
Follow-up to 54 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with therapy-resistant pruritus due to chronic liver disease
Key exclusion criteria
Patients with a history of allergy to the ingredients in Nalfurafine Hydrochloride
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1111
alfsg@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Nakayama |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1111
Homepage URL
alfsg@saitama-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Saitama 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
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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | 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 | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025634
