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A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218501
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.

Condition or disease Intervention/treatment Phase
Uremic Pruritus in Hemodialysis Patients Drug: SK-1405 high dose Drug: SK-1405 low dose Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arm Intervention/treatment
Active Comparator: SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks
Drug: SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks

Active Comparator: SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks
Drug: SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks

Placebo Comparator: Placebo
Placebo is to be administered orally once daily for 2 weeks
Drug: Placebo
Placebo is to be administered orally once daily for 2 weeks




Primary Outcome Measures :
  1. Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 1 week, 3 weeks ]
  2. Change from baseline in Itch Severity Assessment [ Time Frame: 1 week, 2 weeks, 3 weeks ]
  3. Change from baseline in Sleep Quality Assessment [ Time Frame: 1 week, 2 weeks, 3 weeks ]
  4. Change from baseline in 5D Itch Scale [ Time Frame: 2 weeks ]
  5. Number of Participants with Adverse Events [ Time Frame: 5 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving hemodialysis three times a week for at least 12 weeks
  • 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:

  • Complications that may affect the assessment of uremic pruritus
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218501


Locations
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Japan
Investigational site (there may be other sites in this country)
Tokyo, Japan
Sponsors and Collaborators
Sanwa Kagaku Kenkyusho Co., Ltd.

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Responsible Party: Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03218501     History of Changes
Other Study ID Numbers: MO1003
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanwa Kagaku Kenkyusho Co., Ltd.:
Uremic Pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms