Neuropathic Pain Clinical Trial
Official title:
Multinational, Multicenter, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
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.
Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3 week follow-up period. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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