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Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis

NCT01513161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2012-01-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.

Conditions

  • Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis

Interventions

DRUG

nalfurafine hydrochloride (TRK-820)

Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.

DRUG

Placebo

Sponsors & Collaborators

  • Toray Industries, Inc

    collaborator INDUSTRY

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Suhng Gwon Kim, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513161 on ClinicalTrials.gov