Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: SAR292833; Drug: placebo

• 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.

Study Timeline

• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-28
• Disposition First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Disposition First Posted: 2016-02-26
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

Exclusion Criteria

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
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
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 Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC).	4 weeks

Trial Locations

Locations (61)

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

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

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