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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia

Treatments: Drug: DS-5565

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607280

DS5565-A-J313

Details and patient eligibility

About

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.

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

DS-5565 group

Experimental group

Description:

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

Treatment:

Drug: DS-5565