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

Primary Purpose

Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

DS-5565

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring Diabetic peripheral neuropathic pain, post-herpetic neuralgia, renal impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Shonan Kamakura General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DS-5565 group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02607280

First Posted

November 16, 2015

Last Updated

April 16, 2021

Sponsor

Daiichi Sankyo Co., Ltd.

Collaborators

CMIC Co, Ltd. Japan

1. Study Identification

Unique Protocol Identification Number

NCT02607280

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daiichi Sankyo Co., Ltd.

Collaborators

CMIC Co, Ltd. Japan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia

Keywords

Diabetic peripheral neuropathic pain, post-herpetic neuralgia, renal impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DS-5565 group

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

DS-5565

Other Intervention Name(s)

mirogabalin

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

Baseline to Week 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Study Leader

Organizational Affiliation

Daiichi Sankyo, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Shonan Kamakura General Hospital

City

Kamakura-shi

State/Province

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing URL

https://vivli.org/ourmember/daiichi-sankyo/

Citations:

PubMed Identifier

32765056

Citation

Baba M, Takatsuna H, Matsui N, Ohwada S. Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study. J Pain Res. 2020 Jul 17;13:1811-1821. doi: 10.2147/JPR.S255345. eCollection 2020.

Results Reference

derived

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

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