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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02318706
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathic Pain Drug: DS-5565 Drug: placebo Phase 3

Detailed Description:

[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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : June 29, 2017

Arm Intervention/treatment
Placebo Comparator: placebo
placebo group (14 weeks)
Drug: placebo
Experimental: DS-5565 15mg
DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Drug: DS-5565
Other Name: mirogabalin

Experimental: DS-5565 20 mg group
DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
Drug: DS-5565
Other Name: mirogabalin

Experimental: DS-5565 30 mg group
DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Drug: DS-5565
Other Name: mirogabalin




Primary Outcome Measures :
  1. Change in the Average Daily Pain Score (ADPS) [ Time Frame: baseline to week 14 ]
    Change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus Placebo



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318706


Locations
Japan
Saiki Central Hospital
Oita, Japan, 876-0851
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02318706     History of Changes
Other Study ID Numbers: DS5565-A-J303
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Diabetic Peripheral Neuropathic Pain

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases