NCT01504412

Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	DS-5565	Oral tablets administered twice daily
DRUG	DS-5565	Oral tablets administered twice daily
DRUG	DS-5565	Oral tablets administered twice daily
DRUG	Placebo	DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
DRUG	Pregabalin capsules	Pregabalin oral capsules 150 mg administered twice a day

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-01-05
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

3 sites across 3 countries: Japan, South Korea, Taiwan