Unique ID issued by UMIN | UMIN000028161 |
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Receipt number | R000032233 |
Scientific Title | Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study |
Date of disclosure of the study information | 2017/07/12 |
Last modified on | 2017/07/12 08:18:01 |
Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Nalfurafine hydrochloride and chronic liver diseases
Effect of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus on sleep disorders: A study protocol for prospective interventional study
Nalfurafine hydrochloride and chronic liver diseases
Japan |
Chronic liver disease patients with refractory pruritus
Hepato-biliary-pancreatic medicine |
Others
NO
The aims of the current study is to examine the impact of study drug on sleep quality for CLD patients with pruritus usng actigram.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Sleep related variables using actigram
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Study drug (1 cap per day) will be prescribed orally after dinner or before going to bed.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with hepatic inflammation persisting for at least 6 months
Patients who were not expected to show rapid changes in the general status
Patients whose pruritus was regarded as to be uncontrollable by medicines within 6 months before IC.
(1)Patients with past history for hypersensitivity for the ingredients of testing drugs.
(2)Female patients with pregnancy or suspected of being pregnant, or those desiring pregnancy during study period.
(3)Lactating female patients
(4)Patients who were judged to be inappropriate for the study subjects
50
1st name | |
Middle name | |
Last name | Shuhei Nishiguchi |
Hyogo college of medicine
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
0798-45-6111
kantan@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | kazunori Yoh |
Hyogo college of medicine
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
0798-45-6111
mm2wintwin@ybb.ne.jp
Hyogo college of medicine
Hyogo college of medicine
Other
NO
2017 | Year | 07 | Month | 12 | Day |
Unpublished
Preinitiation
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 08 | Month | 10 | Day |
2017 | Year | 07 | Month | 10 | Day |
2017 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032233
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