DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

Launched by DAIICHI SANKYO CO., LTD. · Nov 17, 2015

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
• • At screening, a pain scale of ≥ 40 mm
• • Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
• • post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)
• Exclusion Criteria:
• • HbA1c (National Glycohemoglobin Standardization Program) \> 10.0% (for patients with DPNP only)
• • Previous use of neurolytic block (for patients with PHN only)