Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
- Registration Number
- NCT01463397
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3 week follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR292833 dose level 1 SAR292833 Dose level 1 twice daily immediately after breakfast/dinner SAR292833 dose level 2 SAR292833 Dose level 2 twice daily immediately after breakfast/dinner Placebo placebo Placebo (for SAR292833) twice daily immediately after breakfast/dinner
- Primary Outcome Measures
Name Time Method Change from baseline in the average daily pain intensity as measured by the 11-point NRS; Baseline to 4 weeks The average daily pain intensity is the mean of the last consecutive 7 days.
- Secondary Outcome Measures
Name Time Method 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; Baseline to 4 weeks Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline Baseline to 4 weeks Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS) Baseline to 4 weeks Amount of and time to first rescue medication intake during the treatment period. 4 weeks Change in Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC). 4 weeks
Trial Locations
- Locations (61)
Investigational Site Number 616001
🇵🇱Bydgoszcz, Poland
Investigational Site Number 840014
🇺🇸Tucson, Arizona, United States
Investigational Site Number 840038
🇺🇸Santa Ana, California, United States
Investigational Site Number 840012
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 840007
🇺🇸Garden Grove, California, United States
Investigational Site Number 616007
🇵🇱Sandomierz, Poland
Investigational Site Number 348002
🇭🇺Budapest, Hungary
Investigational Site Number 643006
🇷🇺Kazan, Russian Federation
Investigational Site Number 643005
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 348006
🇭🇺Debrecen, Hungary
Investigational Site Number 840015
🇺🇸Raleigh, North Carolina, United States
Investigational Site Number 840020
🇺🇸Newport Beach, California, United States
Investigational Site Number 840002
🇺🇸Tustin, California, United States
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 840004
🇺🇸Springfield, Massachusetts, United States
Investigational Site Number 840042
🇺🇸Framingham, Massachusetts, United States
Investigational Site Number 840035
🇺🇸St. Louis, Missouri, United States
Investigational Site Number 840010
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840037
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 840040
🇺🇸Hartsdale, New York, United States
Investigational Site Number 840033
🇺🇸Rochester, New York, United States
Investigational Site Number 840001
🇺🇸New York, New York, United States
Investigational Site Number 840017
🇺🇸Toledo, Ohio, United States
Investigational Site Number 840044
🇺🇸Altoona, Pennsylvania, United States
Investigational Site Number 840022
🇺🇸Winston Salem, North Carolina, United States
Investigational Site Number 840018
🇺🇸Johnstown, Pennsylvania, United States
Investigational Site Number 840043
🇺🇸Dallas, Texas, United States
Investigational Site Number 840045
🇺🇸Tullahoma, Tennessee, United States
Investigational Site Number 840006
🇺🇸Austin, Texas, United States
Investigational Site Number 840032
🇺🇸Dallas, Texas, United States
Investigational Site Number 203002
🇨🇿Olomouc, Czech Republic
Investigational Site Number 840016
🇺🇸Seattle, Washington, United States
Investigational Site Number 203005
🇨🇿Praha 10, Czech Republic
Investigational Site Number 203006
🇨🇿Praha 10, Czech Republic
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 348005
🇭🇺Budapest, Hungary
Investigational Site Number 348007
🇭🇺Budapest, Hungary
Investigational Site Number 348003
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 616002
🇵🇱Lublin, Poland
Investigational Site Number 616004
🇵🇱Wloclawek, Poland
Investigational Site Number 643007
🇷🇺Kazan, Russian Federation
Investigational Site Number 643010
🇷🇺Moscow, Russian Federation
Investigational Site Number 643009
🇷🇺Moscow, Russian Federation
Investigational Site Number 643008
🇷🇺Moscow, Russian Federation
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 643004
🇷🇺Nizhny Novgorod, Russian Federation
Investigational Site Number 643012
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 643011
🇷🇺Moscow, Russian Federation
Investigational Site Number 643013
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643003
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 804005
🇺🇦Kiev, Ukraine
Investigational Site Number 643014
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 703004
🇸🇰Banska Bystrica, Slovakia
Investigational Site Number 703001
🇸🇰Dubnica Nad Vahom, Slovakia
Investigational Site Number 703003
🇸🇰Krompachy, Slovakia
Investigational Site Number 804002
🇺🇦Kiev, Ukraine
Investigational Site Number 804004
🇺🇦Kyiv, Ukraine
Investigational Site Number 804003
🇺🇦Kyiv, Ukraine
Investigational Site Number 840019
🇺🇸Evansville, Indiana, United States