NCT00375960

A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Vernalis (R&D) Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.

Detailed description

Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.

Conditions

• Pain
• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	V3381
DRUG	Placebo

Timeline

• Start date: 2006-06-01
• Completion: 2007-04-01
• First posted: 2006-09-13
• Last updated: 2007-04-02

Locations

6 sites across 2 countries: United States, Canada