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Clinical Trial 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.


Clinical Trial Description

Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3 week follow-up period. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01463397
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date March 2012
Completion date May 2013

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