Conditions: Uremic Pruritus
Keywords: Pruritus Renal dialysis Receptors, Opioid, kappa Sleep Disorders Quality of Life
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

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

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Nalfurafine hydrochloride(MT-9938) 2.5μg intervention 2: Nalfurafine hydrochloride(MT-9938) 5μg intervention 3: Nalfurafine hydrochloride(MT-9938) 10μg intervention 4: Placebo
Intervention descriptions: intervention 1: 2.5 μg (2capsules) once daily for 8 weeks intervention 2: 5 μg (2capsules) once daily for 8 weeks intervention 3: 10 μg (2capsules) once daily for 8 weeks intervention 4: Placebo (2capsules) once daily for 8 weeks

Protocol document: