A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
NCT ID: NCT03218501
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
269 participants
INTERVENTIONAL
2017-08-28
2018-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks
SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo
Placebo is to be administered orally once daily for 2 weeks
Placebo
Placebo is to be administered orally once daily for 2 weeks
Interventions
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SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo
Placebo is to be administered orally once daily for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
* Mean worst itching VAS is 50 mm or more in both the first and second observation periods
Exclusion Criteria
* Started or changed pruritus treatment within 13 days prior to starting observations
* Received ultraviolet treatment within 27 days prior to starting observations
* Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
* Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
* Pregnancy, or breastfeeding
20 Years
ALL
No
Sponsors
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Sanwa Kagaku Kenkyusho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Investigational site (there may be other sites in this country)
Tokyo, , Japan
Countries
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Other Identifiers
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MO1003
Identifier Type: -
Identifier Source: org_study_id
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