Neuropathic pain MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Product Code: SAR292833
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: SAR292833
Pharmaceutical Fo
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
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 distinct neuroanatomically plausible distribution with sensory signs and symptoms confirmed by DN4 (Douleur Neuropathique en 4 questions) score of =4 and being present for more than 3 months. SAR292833 should be taken in fed condition. Therefore, only patients who were judged to be reliable to fulfill this condition (used to have breakfast and dinner) will be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 99 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 99
Exclusion criteria
Exclusion criteria: Patients with a baseline average daily pain intensity for their neuropathic pain 150 µmol/L; ALT 3 x ULN; Total bilirubin > 1.5 x ULN except known Gilbert syndrome; Presence of signs of clinically significant abnormalities on a standard electrocardiogram (ECG) recording at the screening visit according to Investigator's medical judgment; Pregnant or breastfeeding women Women of childbearing potential (WOCBP), not protected by highly effective contraceptive method of birth control; Patients with diabetes mellitus and time between diagnosis of diabetes and enrolment 10% or fasting plasma glucose >250 mg/dL; Use of the following drugs within 7 days prior to start with the pain intensity assessment (Visit 2): Antidepressants (except for stable [>30 days]regimens of Selective serotonin reuptake inhibitors (SSRIs) for treatment of anxiety or depression), anticonvulsants or mexiletine for the treatment of pain; Opioids or morphinomimetics; Fatty acid supplements, primrose oil, myoinositol, chromium picolinate that are known to be used in neuropathic pain; Acetyl salicylic acid (ASA) except up to 325 mg/d for myocardial infarction or transient ischemic attack prophylaxis; Benzodiazepines other than indicated at low doses for sleep disorders; Capsaicin patch; Lidocaine patch; Electroconvulsive therapy within 30 days of baseline evaluation; CYP3A4 potent and moderate inhibitors; CYP3A4 potent and moderate inducers; Substrates of CYP3A4 with narrow therapeutic window.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: 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.;Primary end point(s): Change from baseline to the 4th week of treatment in the average daily pain intensity as measured by the 11-point NRS; the average daily pain intensity is the mean of the last consecutive 7 days.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 • Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline • Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS) • Amount of and time to first rescue medication intake during the treatment period • Change in sleep (DSIS), global impression of change (PGIC and CGIC) ;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Czech Republic, Hungary, Poland, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactNA.
sanofi aventis Zrt.
Outcome results
None listed