Phase 3 N=834 Randomized Double-blind Treatment

DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02318706 ↗

Enrolled (actual)

834

Serious AEs

5.6%

Results posted

Nov 2020

Primary outcome: Primary: 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 — -0.26; -0.39; -0.40; -0.60 units on a scale — p=0.8773

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DS-5565 (Drug); placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-0.26; -0.39; -0.40; -0.60; -0.46; -0.60	0.8773
SECONDARY Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain	-0.90; -4.00; -7.00; -6.20; -7.20; -7.80	—

Summary

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

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%

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02318706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.