Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.