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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborator: CMIC Co, Ltd. Japan

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)