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SAR292833

Phase 2

Neuropathic Pain | Small molecule | Pain |Sanofi|Last Updated: Feb 26, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment191

FDA Designations

No designations recorded

Clinical trial landscape

SAR292833 · 1 trial · 1 indication

Phase 2 1
NCT01463397Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic PainNeuropathic Pain
COMPLETED191 Analytics
PHASE2COMPLETED
Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR292833 dose level 1EXPERIMENTALDose level 1 twice daily immediately after breakfast/dinner
SAR292833 dose level 2EXPERIMENTALDose level 2 twice daily immediately after breakfast/dinner
PlaceboPLACEBO_COMPARATORPlacebo (for SAR292833) twice daily immediately after breakfast/dinner

Interventions

NameTypeDescription
SAR292833DRUGPharmaceutical form: capsule Route of administration: oral
placeboDRUGPharmaceutical form:capsule Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion criteria: -The study will include adult patients of either gender, 18 - 85 of age, who have signed the informed consent form, and presenting with chronic peripheral neuropathic pain associated with: diabetic polyneuropathy, post-herpetic neuralgia. * The neuropathic pain must have a dist...

Countries:United StatesCzechiaHungaryPolandRussiaSlovakiaUkraine
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Frequently asked questions about SAR292833

What is SAR292833 used for?

SAR292833 is an investigational small molecule being developed for the treatment of chronic peripheral neuropathic pain. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes SAR292833?

SAR292833 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for neuropathic pain.

What phase is SAR292833 in?

SAR292833 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved for commercial use.

What clinical trials is SAR292833 in?

SAR292833 has one completed clinical trial, NCT01463397, which evaluated its efficacy and safety over 4 weeks in patients with chronic peripheral neuropathic pain. The trial enrolled 191 participants across multiple countries, including the United States, Czechia, Hungary, Poland, Russia, Slovakia, and Ukraine.

Is SAR292833 FDA approved?

SAR292833 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for neuropathic pain. The completed Phase 2 trial was a randomized, double-blind, placebo-controlled study, but the drug has not yet received regulatory approval.