Phase 2 N=450 Randomized Double-blind Treatment

Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

Pain · Diabetic Peripheral Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT01504412 ↗

Enrolled (actual)

450

Serious AEs

2.7%

Results posted

Mar 2020

Primary outcome: Primary: Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy — -0.59; -0.71; -0.69; -0.88 units on a scale — p=0.1995

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: DS-5565 (Drug); Placebo (Drug); Pregabalin capsules (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	-0.59; -0.71; -0.69; -0.88; -0.60; -0.86	0.1995
SECONDARY Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy	-16.7; -17.2; -21.9; -22.1; -24.2	0.0691

Summary

The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Eligibility Criteria

Inclusion Criteria

Type 1 or Type 2 diabetes mellitus
Painful distal symmetric polyneuropathy
Average daily pain score is great than or equal to 4

Exclusion Criteria

HbA1c greater than 9.0

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01504412). 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.