NCT01314222

Diabetic Peripheral Neuropathic Pain (DPNP)

A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

Detailed description

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	BMS-954561
DRUG	Pregabalin
DRUG	Placebo matching BMS-954561
DRUG	Placebo matching Pregabalin

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2011-03-14
• Last updated: 2015-12-07

Locations

24 sites across 2 countries: United States, France