Diabetic peripheral neuropathic pain MedDRA version: 12.0 Level: LLT Classification code 10067547 Term: Diabetic peripheral neuropathic pain
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with painful diabetic neuropathy The neuropathic pain must have a distinct, neuroanatomically plausible distribution demonstrated by at least one confirmatory test (e.g., clinical sensory examination, electrophysiology); 2. Having given written informed consent prior to any procedure related to 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to study metho 1. Patients 10 %; 5. Patients with history of hypoglycaemia unawareness; 6. Patients with a history of hypoglycaemia with unconsciousness during the last 3 mths prior to the study, ketoacidosis, hyperosmolar coma, major changes in diabetes therapy 7. Patients with any conditions other than the diabetic neuropathic pain that cause pain of equal or greater severity; 8. Patients with abnormal folate and/or vitamin B12 that could be the cause of the neuropathic pain, and need to be corrected; 9. Patients with hypothyreosis as shown by elevated TSH; 10. Patients receiving analgesic medication for conditions other than diabetic neuropathic pain; 11. Patients with previous treatment failure to > 2 approved treatment regimens for neuropathic pain of adequate doses and duration; 12. Patients not willing to washout of all analgesic medications prior to the start of study treatment (except paracetamol/acetaminophen); 13. Patients with severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological psychiatric, hematological, renal, dermatological disease, progressive malignancy, hepatobiliary disease or any other medical condition that might interfere with the evaluation of study medication according to investigator’s medical judgment; 14. Laboratory parameters outside the normal range unless the investigator considers an abnormality as clinically not relevant for these patients; 15. Patients with contraindications for paracetamol treatment 16. Creatinine clearance 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening; if on antihypertensive treatment: treatment should have been stable during the last 3 mths prior to the study; 19. Patients using the following drugs within 5-times the half-life prior to start with the baseline pain intensity assessment (Visit 1 or 2) before the randomization visit: antidepressants, anticonvulsants or mexiletine for the treatment of pain, opioids or morphinomimetics, fatty acid supplements, primrose oil, myoinositol, chromium picolinate, alpha-lipoic acid, benfotiamin that are known to be used in neuropathic pain, acetyl salicylic acid more than 325 mg/day and not indicated for myocardial infarction or transient ischemic attack prophylaxis, NSAIDs for the treatment of pain, benzodiazepines other than indicated at low doses for sleep disorders, muscle relaxants, any drugs containing paracetamol/acetaminophen, OCT2 inhibitors such as cimetidine, ofloxacin, levofloxacin, phenazopyridine, piliscainide, quinidine, quinine, ranitidine 20. Electroconvulsive therapy within 30 days of baseline evaluation (Visit 3); 21. Regular use of capsaicin in the 6 mths before the study; 22. Prior neurolytic treatment or intrathecal pumps for treatment of pain; 23. Physiotherapy if not stable 1 mth before and during the study; 24. Patients with short life expectancy; 25. Patients with a history of HIV infection and/or with active hepatitis B or C; 26
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SAR407899A administered at 15 mg twice daily for 28 days in comparison to placebo in reducing pain intensity in patients with painful diabetic neuropathy as measured on the 11 point numerical rating scale (NRS).;Secondary Objective: To investigate the safety and tolerability of 15 mg SAR407899A twice daily in comparison to placebo. To compare the effects of SAR407899A with placebo on the change of pain intensity versus baseline by using the following scales and clinical tests: - The Visual Analog Scale Pain Intensity Scale, - The Visual Analog Scale Pain Relief Scale, - The Neuropathic Pain Symptom Inventory. To evaluate the effects of SAR407899A in comparison to placebo on the change in pain intensity of mechanical allodynia. To evaluate the use of rescue medication (paracetamol) in SAR407899A-treated patients in comparison to placebo-treated patients. To assess the exposure to SAR407899A.;Primary end point(s): Change in the average daily pain intensity as measured on the 11 point NRS defined as the mean of the last 7 days of the treatment period compared to baseline. | — |
Countries
Austria, Germany, Hungary
Outcome results
None listed