Conditions: Diabetic Peripheral Neuropathic Pain Post-herpetic Neuralgia
Keywords: Diabetic peripheral neuropathic pain post-herpetic neuralgia renal impairment
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

Detailed description:
The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Arms:
arm 1: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Interventions: intervention 1: DS-5565
Intervention descriptions: intervention 1: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Protocol document:
Prot_SAP_000.pdf: