EFFICACY AND SAFETY OF SAR292833 ADMINISTRATION FOR 4 WEEKS IN PATIENTS WITH CHRONIC PERIPHERAL NEUROPATHIC PAI
- Conditions
- europathic painMedDRA version: 14.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-001876-21-HU
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 198
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
Patients with a baseline average daily pain intensity for their neuropathic pain < 5 on the 11-point NRS over the last consecutive 7 days before randomization;
Patients with a pain intensity of = 9 on the 11 point NRS at Visit 1;
Any pain other than the neuropathic pain of equal or greater severity;
Sensory polyneuropathy post chemotherapy or in the context of cancer or AIDS;
Patients with complex regional pain syndrome;
Trigeminal neuralgia;
Patients with clinically significant or uncontrolled hepatic, metabolic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication according to Investigator's medical judgment;
Patients on statins metabolized by CYP3A4, (e.g. simvastatin, atorvastatin) and abnormal CPK level;
Major depression;
Serum creatinine >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 <6 months;
Patients with diabetes mellitus and HbA1c >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method