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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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).

Detailed Summary: This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
Sponsor: Toray Industries, Inc

Current Primary Outcome:

  • Change from baseline in Worst-itching 11-point Numerical Rating Scale (NRS) [ Time Frame: 2 weeks, 4 weeks and 8 week ]
  • Change from baseline in Worst-itching Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
  • Change from baseline in Itch Severity Score [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
  • Change from baseline in Sleep quality assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
  • Change from baseline in Excoriation [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
  • Change from baseline in QoL assessment [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]
  • Change from baseline in Treatment satisfaction (Patient's Global Impression of Change ) [ Time Frame: 2 weeks, 4 weeks and 8 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]

Original Secondary Outcome: Same as current

Information By: Toray Industries, Inc

Dates:
Date Received: August 2, 2012
Date Started: September 2012
Date Completion:
Last Updated: February 18, 2016
Last Verified: February 2016