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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
191
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form:capsule Route of administration: oral
Investigational Site Number 840014
Tucson, Arizona, United States
Investigational Site Number 840007
Garden Grove, California, United States
Investigational Site Number 840020
Newport Beach, California, United States
Investigational Site Number 840038
Santa Ana, California, United States
Investigational Site Number 840002
Tustin, California, United States
Change from baseline in the average daily pain intensity as measured by the 11-point NRS;
The average daily pain intensity is the mean of the last consecutive 7 days.
Time frame: Baseline to 4 weeks
Percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline derived from the primary efficacy endpoint;
Time frame: Baseline to 4 weeks
Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline
Time frame: Baseline to 4 weeks
Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS)
Time frame: Baseline to 4 weeks
Amount of and time to first rescue medication intake during the treatment period.
Time frame: 4 weeks
Change in Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC).
Time frame: 4 weeks
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Investigational Site Number 840046
Coral Gables, Florida, United States
Investigational Site Number 840013
Ocala, Florida, United States
Investigational Site Number 840034
Palm Beach Gardens, Florida, United States
Investigational Site Number 840019
Evansville, Indiana, United States
Investigational Site Number 840012
Indianapolis, Indiana, United States
...and 51 more locations