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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033255
Receipt No. 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 2019/02/20

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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
Last name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL +81734472300
Email kitano@wakayama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Ryo Shimizu
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL +81734472300
Homepage URL
Email rshimizu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 05 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
2018 Year 07 Month 03 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037908

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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