DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Launched by DAIICHI SANKYO CO., LTD. · Dec 11, 2014
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
\[Double Blind Phase\] 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.
Gender
ALL
Eligibility 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%
About Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd. is a global healthcare company headquartered in Tokyo, Japan, renowned for its commitment to innovative research and development in pharmaceuticals. With a rich history spanning over a century, the company focuses on delivering transformative treatments across various therapeutic areas, including oncology, cardiovascular disease, and infectious diseases. Daiichi Sankyo leverages cutting-edge science and technology to advance its drug development pipeline, emphasizing collaboration and partnership to enhance patient outcomes worldwide. Its dedication to improving global health is reflected in its extensive clinical trials, which aim to bring novel therapies to market and address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oita, , Japan
Patients applied
Trial Officials
Global Clinical Leader
Study Director
Daiichi Sankyo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials