A dose-finding study of efficacy and safety of F13640 in patients with moderate to severe painful peripheral diabetic polyneuropathy - BEST- Diabetes study (Befiradol Dose-Finding Study in diabetic patients)

• Conditions: diabetic peripheral neuropathy; MedDRA version: 9.1Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathy

• Registration Number: EUCTR2009-012123-28-CZ
• Lead Sponsor: Institut de Recherche Pierre Fabre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-21
• Last Update Posted: 19 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Outpatient, man or woman, 18 to 65 years old
- Woman of childbearing potential must have been using an effective method of contraception (defined as chirurgical or hormonal birth control, or intra-uterine device only), 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)
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 <10 % at selection
Pain persisting for more than 3 months
- Average 24-hour recall pain intensity score > 40 and < 90 on a 0-100 Visual Analogue Scale (VAS) at selection visit
- Average 24-hour recall pain intensity score in the PED > 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

- 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 < 50 ml/min)
- Presence of significant nociceptive, inflammatory or central neuropathic pain
- Presence of vascular chronic pain, with particular regard for severe diabetic arteriopathy of the lower limbs characterised by the presence of ulceration and/or necrosis
- Phantom pain
- Complex Regional Pain Syndrome
- Physical techniques, surgery and psychological support that can modulate the perception of pain (except if maintained stable during the trial when unavoidable
- AST/SGOT and ALT/SGPT greater than 2 time the upper normal values
- Blood creatinine value > 150 µmol/L
- Albuminuria/creatininuria > 300 mg/g
- SBP < 120 mm Hg (at selection and randomisation, in supine position, and after a 10 min-rest)
- ECG: QTc > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified