diabetic peripheral neuropathy MedDRA version: 9.1 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy
Conditions
Interventions
Product Name: befiradol
Product Code: F13640
Pharmaceutical Form: Tablet
INN or Proposed INN: befiradol
CAS Number: 208110-64-9
Sponsors
Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Outpatient, man or woman, 18 to 65 years old - Woman of childbearing potential must have been using an effective method of contraception, as assessed by the investigator, for at least 2 months before selection in the study, and must accept to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment, in order to avoid pregnancy while being exposed to the study treatment A pregnancy test will be carried out at selection visit, at randomisation visit and at the last study visit of the patient. - Moderate to severe painful peripheral diabetic polyneuropathy with the 4 following characteristics: Diagnosis based on clinical examination, and appropriate assessment of patient’s signs and symptoms (clinical portion of Michigan Neuropathy Screening Instrument score ³ 3) Following diabetes mellitus type 1 or 2, diagnosed for at least 3 years with stable glycaemic assessment for at least 3 months Haemoglobin A1c (HbA1c) level 40 and 40 on a 0-100 unit VAS, over the week preceding randomisation visit (at least 4 assessable days) -Affiliated to a social security system, or is a beneficiary, if applicable in the national regulation -Patient having signed his/her written informed consent -Patient able and willing to use the PED device daily for the duration of the study; able to hear and respond to the PED audible prompts, able to read and understand the text in local language on the PED screen 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: - Any clinically significant hepatic, renal, gastro-intestinal, endocrinal (excluding diabetes mellitus), cardiovascular, neurological, psychiatric or haematological or current disease unrelated to the cause of pain, which may interfere with pain evaluation, patient safety and the course of the study in the investigator’s opinion - Current major depressive disorder requiring a pharmacological treatment - Severe nephropathy (creatinin clearance 150 µmol/L - Albuminuria/creatininuria > 300 mg/g/1,73m² - SBP 450 ms - History of alcohol or narcotic drug dependence in the 2 years preceding the selection or alcohol or narcotic abuse in the 6 months preceding the selection - Known hyper-reactivity or hyper-sensitivity to 5-HT agonists - Intake of any prohibited treatments which cannot be stopped - For patient having been treated by prohibited treatments, no respect of a wash-out period of at least 5 T1/2 of the treatment prior to randomisation - Woman pregnant or in the post-partum period (at least 6 months) or is a nursing mother - Woman sterile or in post-menopause state (12 month-amenorrhoea) impossible to document - Is a family member or work associate (secretary, nurse, technician,…) of the Investigator - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself / herself to its constraints - Has participated in another clinical trial within the last 3 month(s), has received treatment with known remanant effects or undergone investigation liable to interfere with the present clinical trial - Has forfeited his / her freedom by administrative or legal award or is under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first study objective is to define the dose-response relationship of F13640 compared to a placebo with respect to analgesic efficacy and safety in patients with moderate to severe painful peripheral diabetic polyneuropathy.;Secondary Objective: The second objectives are the evaluation of potential rebound effect, addiction effect and remanent dose effect after study treatment discontinuation.;Primary end point(s): Response to treatment defined as a decrease of at least 30% on the weekly average 24-hour recall pain intensity score on a 0-100 Visual Analogue Scale (VAS), between the baseline (the last week before the first study drug intake, scheduled on D1) and the last week before the end of fixed dose period (D56 or End of Fixed Dose visit –EFD-). Patients who discontinued prematurely fixed dose for insufficient response and/or worsening will be classified as non-responders. For patients having taken rescue medication and for patients who take non-allowed concomitant treatment during the last week before the end of fixed dose period, Validation Committee will decide whether he (she) is a responder or not. | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Lithuania, Slovakia
Outcome results
None listed