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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318706
Recruitment Status : Completed
First Posted : December 17, 2014
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborators:
CMIC Co, Ltd. Japan
Quintiles, Inc.
Quintiles Malaysia Sdn. Bhd.
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 854 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) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain [ Time Frame: Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg]) ]

    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 :
  1. Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain [ Time Frame: From baseline (Week 14) to Week 66 ]

    Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome.

    In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.




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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
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Japan
Saiki Central Hospital
Oita, Japan, 876-0851
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
CMIC Co, Ltd. Japan
Quintiles, Inc.
Quintiles Malaysia Sdn. Bhd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
  Study Documents (Full-Text)

Documents provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02318706    
Other Study ID Numbers: DS5565-A-J303
First Posted: December 17, 2014    Key Record Dates
Results First Posted: November 2, 2020
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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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:
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Neuralgia
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases