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

Daiichi Sankyo Co., Ltd.35 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Peripheral Neuropathic Pain Post-herpetic Neuralgia

Interventions

DS-5565DRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (1)

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Outcomes

Primary Outcomes

Change From Baseline in Average Daily Pain Score (ADPS) at Each Week

Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.

Time frame: Baseline to Week 14

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.