UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033255 |
|---|---|
| Receipt number | R000037908 |
| Scientific Title | Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2021/02/24 11:59:27 |
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Basic information
Public title
Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Acronym
Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Scientific Title
Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Scientific Title:Acronym
Pilot Study of efficacy and safety of nalfurafine hydrochloride for jaundice associated pruritus
Region
| Japan |
Condition
Condition
Pruritus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare with efficacy of nalfurafine hydrochloride and fexofenadine hydrochloride in obstructive jaundice patients with pruritus and chronic hepatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare with curative effect for pruritus in 2 weeks later medicating between "nalfurafine hydrochloride group" and "fexofenadine hydrochloride group".
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nalfuraine hydrochloride group
Interventions/Control_2
fexofenadine hydrochloride group
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
Obstructive jaundice patients with hyperbilirubinemia (serum bilirubin levels are over 3mg/dL).
Chronic hepatitis patients diagnosed with blood test and/or imaging examination.
Patients have itchiness.
Informed consent must be obtained from patients themselves.
Key exclusion criteria
Patient's consciousness are not alert.
Presence of hypersensitivity to nalfurafine hydrochloride and/or fexofenadine hydrochloride.
Presence of other dermatosis except for jaundice associated pruritis.
Presence of sever organopathy and/or drug allergy.
Patients who pregnant or possibility of pregnant, lactating and desire for childbearing.
Difficult to ingestion.
Ineligible cases are judged by researchers.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL
+81734472300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Shimizu |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL
+81734472300
Homepage URL
rshimizu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama 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
Reserch Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel
+81734472300
wa-rinri@wakayama-med.ac.jp
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
| 2018 | Year | 07 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037908
