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

Phase 3

Completed

• Conditions: Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia
• Interventions: Drug: DS-5565

• Registration Number: NCT02607280
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Study Start: 2015-12
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2020-09-30
• Results First Submitted QC: 2020-09-30
• Results First Posted: 2020-10-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DS-5565 group	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week	Baseline to Week 14	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.

Trial Locations

Locations (1)

Shonan Kamakura General Hospital; 🇯🇵 Kamakura-shi, Kanagawa, Japan