NCT00927914

Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.

Conditions

• Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Interventions

Type	Name	Description
DRUG	Ranirestat	Ranirestat 40 mg tablets
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2009-06-25
• Last updated: 2019-02-21

Locations

1 site across 1 country: United States