Efficacy and safety of SAR407899A in patients with painful diabetic neuropathy. A 28-day, randomized, double-blind, placebo-controlled, parallel-group study.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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

Related to study metho
1. Patients < 18 years or = 70 years of age;
2. Average daily pain intensity for neuropathic pain < 4 on the 11-point NRS over the last 3 days before rando;
3. Patients in whom the time between diagnosis of diabetic neuropathy and study start is < 6 mths;
4. Patients with HbA1c > 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 < 60 mL/min;
17. Presence of significant abnormalities on a standard electrocardiogram recording at the screening visit according to investigator’s medical judgment (e.g., QTc = 500 ms);
18. Patients with uncontrolled hypertension defined as systolic blood pressure > 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;
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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

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