NCT00307749

Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

Detailed description

The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	Placebo	once daily for 24 weeks
DRUG	MCC-257	20mg, once daily for 24 weeks
DRUG	MCC-257	40mg, once daily for 24 weeks
DRUG	MCC-257	80mg, once daily for 24 weeks

Timeline

• Start date: 2006-03-01
• Completion: 2007-08-01
• First posted: 2006-03-28
• Last updated: 2007-12-28