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

March 7, 2019 updated by: Sanwa Kagaku Kenkyusho Co., Ltd.

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

269

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Investigational site (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Actual)

May 25, 2018

Study Completion (Actual)

May 25, 2018

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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