CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 452 enrolled
Drug / intervention
DS-5565 tablet +3 moredrug
Likely dose
DS-5565 tablet 5mgfrom 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.

Search/NCT01496365
NCT01496365Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Daiichi Sankyo·interventional·Posted Dec 21, 2011·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating DS-5565 tablet, pregabalin capsule, and 2 other interventions for Diabetic Peripheral Neuropathy. Completed, enrolled 452 participants across 78 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2011
Enrollment StartNov 28, 2011
Primary CompletionSep 7, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.5 years ago

Interventions

DS-5565 tabletdrug

5mg and 10mg tablets

pregabalin capsuledrug

75mg and 150mg over-encapsulated

Placebo tabletdrug

placebo capsuledrug