CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 35 enrolled
Drug / intervention
DS-5565drug
Likely dose
DS-5565 15 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.

Search/NCT02607280
NCT02607280Phase 3Completed
CompareCT.gov

A JAPANESE, PHASE 3, OPEN-LABEL, 14-WEEK STUDY OF DS-5565 IN PATIENTS WITH PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY WITH RENAL IMPAIRMENT OR POST-HERPETIC NEURALGIA WITH RENAL IMPAIRMENT

Daiichi Sankyo Co., Ltd.·interventional·Posted Nov 18, 2015·Updated May 13, 2021

In Brief

A Phase 3 clinical trial evaluating DS-5565 for Diabetic Peripheral Neuropathic Pain and Post-herpetic Neuralgia. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia
CountriesJapan
CollaboratorsCMIC Co, Ltd. Japan

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 18, 2015
Enrollment StartDec 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.6 years ago

Interventions

DS-5565drug

DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose