NCT02607280

DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Conditions

• Diabetic Peripheral Neuropathic Pain
• Post-herpetic Neuralgia

Interventions

Type	Name	Description
DRUG	DS-5565	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

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-11-18
• Last updated: 2021-05-13
• Results posted: 2020-10-26

Locations

1 site across 1 country: Japan