Skip to main content
OpenTrials
Completed

NCT Number: NCT02607280

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Peripheral Neuropathic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Post-herpetic Neuralgia Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, 247-8533, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DS-5565

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

Other names: mirogabalin

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Collaborators

  • CMIC Co, Ltd. Japan

Registry information

Official study title

A JAPANESE, PHASE 3, OPEN-LABEL, 14-WEEK STUDY OF DS-5565 IN PATIENTS WITH PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY WITH RENAL IMPAIRMENT OR POST-HERPETIC NEURALGIA WITH RENAL IMPAIRMENT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2015
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.