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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01463397

Public ClinicalTrials.gov record NCT01463397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 3:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01463397
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
191 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2012 (Type not available)
Primary completion
May 2013 (Actual)
Completion
May 2013 (Actual)
Last update posted
Feb 26, 2016

2012 – 2013

United States locations

U.S. sites
28
U.S. states
15
U.S. cities
27
Facility City State ZIP Site status
Investigational Site Number 840014 Tucson Arizona 85741-3565 —
Investigational Site Number 840007 Garden Grove California 92845 —
Investigational Site Number 840020 Newport Beach California 92660 —
Investigational Site Number 840038 Santa Ana California 92705 —
Investigational Site Number 840002 Tustin California 92780 —
Investigational Site Number 840046 Coral Gables Florida 33134 —
Investigational Site Number 840013 Ocala Florida 34471 —
Investigational Site Number 840034 Palm Beach Gardens Florida 33418 —
Investigational Site Number 840019 Evansville Indiana 47714 —
Investigational Site Number 840012 Indianapolis Indiana 46254 —
Investigational Site Number 840042 Framingham Massachusetts 01702 —
Investigational Site Number 840004 Springfield Massachusetts 01104 —
Investigational Site Number 840035 St Louis Missouri 63141 —
Investigational Site Number 840010 Las Vegas Nevada 89148 —
Investigational Site Number 840037 Albuquerque New Mexico 87109 —
Investigational Site Number 840040 Hartsdale New York 10530 —
Investigational Site Number 840001 New York New York 10032 —
Investigational Site Number 840033 Rochester New York 14618 —
Investigational Site Number 840015 Raleigh North Carolina 27612 —
Investigational Site Number 840022 Winston-Salem North Carolina 27103 —
Investigational Site Number 840017 Toledo Ohio 43623 —
Investigational Site Number 840044 Altoona Pennsylvania 16602 —
Investigational Site Number 840018 Johnstown Pennsylvania 19505 —
Investigational Site Number 840045 Tullahoma Tennessee 37388 —
Investigational Site Number 840006 Austin Texas 78731 —
Investigational Site Number 840043 Dallas Texas 75230 —
Investigational Site Number 840032 Dallas Texas 75231 —
Investigational Site Number 840016 Seattle Washington 98122 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01463397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2016 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01463397 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →