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Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

Uremic Pruritus Clinical Trial

Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled, Fixed-dose, Parallel-group, Multicenter, Efficacy, and Safety Study of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

Clinical Trial Summary

This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).

Clinical Trial Description

This study has been terminated because of insufficient patient recruitment. There were no safety concerns. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01660243
Study type Interventional
Source Toray Industries, Inc
Contact
Status Terminated
Phase Phase 2
Start date September 2012
Completion date March 2014
View Details
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