Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain

Summary

Primary Objective: To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS). Secondary Objectives: * To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI); * To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia; * To investigate the safety and tolerability of SAR292833 in comparison to placebo; * To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain.

Timeline

Start

2012-03

Primary completion

2013-05

Completion

2013-05

Drugs

Indications