DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborators: CMIC Co, Ltd. Japan; Quintiles Malaysia Sdn. Bhd.; Quintiles, Inc.

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%