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

NCT01463397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2016-02-26

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain

Interventions

DRUG

SAR292833

Pharmaceutical form: capsule Route of administration: oral

DRUG

placebo

Pharmaceutical form:capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Czechia
  • Hungary
  • Poland
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463397 on ClinicalTrials.gov