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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Quintiles, Inc.
CMIC Co, Ltd. Japan
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT02318706
First received: December 11, 2014
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Condition Intervention Phase
Diabetic Peripheral Neuropathic Pain Drug: DS-5565 Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • 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


Enrollment: 750
Actual Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02318706

Locations
Japan
Saiki Central Hospital
Oita, Japan, 876-0851
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Quintiles, Inc.
CMIC Co, Ltd. Japan
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02318706     History of Changes
Other Study ID Numbers: DS5565-A-J303
Study First Received: December 11, 2014
Last Updated: February 2, 2017

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

ClinicalTrials.gov processed this record on June 27, 2017