CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 854 enrolled
Drug / intervention
DS-5565 +1 moredrug
Likely dose
Not stated in 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/NCT02318706
NCT02318706Phase 3Completed
CompareCT.gov

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension

Daiichi Sankyo Co., Ltd.·interventional·Posted Dec 17, 2014·Updated Nov 2, 2020

In Brief

A Phase 3 clinical trial evaluating DS-5565 and placebo for Diabetic Peripheral Neuropathic Pain. Completed, enrolled 854 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathic Pain
CountriesJapan
CollaboratorsCMIC Co, Ltd. Japan, Quintiles, Inc., Quintiles Malaysia Sdn Bhd

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 17, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.5 years ago

Interventions

DS-5565drug

placebodrug