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

NCT02607280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-05-13

Study results available
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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.

Conditions

  • Diabetic Peripheral Neuropathic Pain
  • Post-herpetic Neuralgia

Interventions

DRUG

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

Sponsors & Collaborators

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Study Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02607280 on ClinicalTrials.gov