NCT01496365

Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life. There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	DS-5565 tablet	5mg and 10mg tablets
DRUG	pregabalin capsule	75mg and 150mg over-encapsulated
DRUG	Placebo tablet
DRUG	placebo capsule

Timeline

• Start date: 2011-11-28
• Primary completion: 2012-09-07
• Completion: 2012-09-07
• First posted: 2011-12-21
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

78 sites across 1 country: United States