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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

NCT ID: NCT02318706

Last Updated: 2020-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

854 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-29

Brief Summary

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Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Detailed Description

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\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.

\[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.

Conditions

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Diabetic Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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placebo

placebo group (14 weeks)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

DS-5565 15mg

DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Group Type EXPERIMENTAL

DS-5565

Intervention Type DRUG

DS-5565 20 mg group

DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose

Group Type EXPERIMENTAL

DS-5565

Intervention Type DRUG

DS-5565 30 mg group

DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Group Type EXPERIMENTAL

DS-5565

Intervention Type DRUG

Interventions

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DS-5565

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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mirogabalin

Eligibility Criteria

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Inclusion Criteria

* Type 1 or type 2 diabetes mellitus at screening
* Painful distal symmetric polyneuropathy
* At screening, a pain scale of ≥ 40 mm

Exclusion Criteria

* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0%
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMIC Co, Ltd. Japan

INDUSTRY

Sponsor Role collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Quintiles Malaysia Sdn Bhd

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Saiki Central Hospital

Ōita, , Japan

Site Status

Countries

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Japan

References

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Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.

Reference Type DERIVED
PMID: 34059327 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DS5565-A-J303

Identifier Type: -

Identifier Source: org_study_id