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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treat

Brief 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.

Detailed Summary:
Sponsor: SK Chemicals Co.,Ltd.

Current Primary Outcome: Change in pruritus degree measured by VAS(Visual Analogue Scale) score [ Time Frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in Shiratori's severity scores assessed by the subject. [ Time Frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products) ]

Original Secondary Outcome: Same as current

Information By: SK Chemicals Co.,Ltd.

Dates:
Date Received: November 23, 2010
Date Started: April 2008
Date Completion:
Last Updated: January 19, 2012
Last Verified: January 2012