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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Diabetic Peripheral Neuropathic Pain Post-herpetic Neuralgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DS-5565 group

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

Group Type EXPERIMENTAL

DS-5565

Intervention Type DRUG

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

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DS-5565

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

Intervention Type DRUG

Other Intervention Names

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mirogabalin

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No