At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 450 enrolled
Drug / intervention
DS-5565 +4 moredrug
Likely dose
Pregabalin capsules 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy
In Brief
A Phase 2 clinical trial evaluating DS-5565, Placebo, and 1 other intervention for Pain and Diabetic Peripheral Neuropathy. Completed, enrolled 450 participants across 3 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Diabetic Peripheral Neuropathy
CountriesJapan, South Korea, Taiwan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionJun 2013
TodayJul 2026
First PostedJan 5, 2012
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.5 years ago
Interventions
DS-5565drug
Oral tablets administered twice daily
DS-5565drug
Oral tablets administered twice daily
DS-5565drug
Oral tablets administered twice daily
Placebodrug
DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
Pregabalin capsulesdrug
Pregabalin oral capsules 150 mg administered twice a day