A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

• Male or female of any race at least 18 years of age
• Female patients must be postmenopausal, or surgically sterilized, or (if they are of
childbearing potential) they must be non-pregnant and non-lactating and must be using appropriate methods of contraception. Prior to starting the trial, it is strongly
recommended that women of childbearing potential use two of the following methods of birth control for at least one month or for whatever amount of time the prescribing doctor determines it will take for the methods of birth control to be fully effective: oral birth control pills, diaphragms, progesterone implanted rods, medroxyprogesterone acetate or condoms. Women of childbearing potential must have a confirmed negative urine pregnancy test at the Screening visit (Visit 1) and Visit 2
• Diagnosis of type 1 or 2 diabetes mellitus (by American Diabetic Association Clinical
Practice Recommendations diagnostic criteria www.diabetes.org) for at least 1 year.
• Hemoglobin A1c levels of =11% at Visit 1 (with fluctuations of =1% in the 6 to 12 weeks prior to Visit 1)
• Diagnosis of painful, distal, symmetrical, sensori-motor polyneuropathy, which is due to diabetes, for at least 1 year.
•Patients at Visit 1 must have a score =40 mm on the Pain Visual Analogue Scale (VAS)
• Patients must be able to understand and cooperate with trial procedures, and have signed a written informed consent prior to entering the trial.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Malignancy within the past 2 years with the exception of basal cell carcinoma
• Patients with significant hepatic impairment (i.e. AST/ALT > 3 x ULN, Total bilirubin >2 x ULN)
• Clinically significant abnormal 12-lead ECG (in the opinion of the investigator)
• Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
• Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
• History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection
• Skin conditions in the area affected by the neuropathy that (in the opinion of the investigator) could alter sensation
• Amputations other than toes
• Administration of any investigational drug and/or agent within 30 days prior to the screening visit
• Use of prohibited medications, in the absence of appropriate washout period
• Abuse of drugs or alcohol within the last 2 years
• Depression sub-scale score >10 on the Hospital and Anxiety Depression Scale
• A current or recent diagnosis (past 6 months) or episode of major depressive disorder (as diagnosed by the MINI) and/or uncontrolled depression (dysthymia as diagnosed by the MINI)
• History of mania, hypomania, psychotic disorder, or current mood disorder with psychotic features
• Any patient judged clinically to be at serious risk of suicide based on Beck’s Scale for Suicide Ideation
• History of recurrent syncope or evidence of low blood pressure (systolic <90mmHg, diastolic <40mmHg)
• Postural hypotension (a fall of 20mmHg in systolic blood pressure or 10mmHg in diastolic blood pressure on standing)
• History of transient ischemic attack or stroke
• Myocardial infarction or unstable angina within the past three months
• Carotid bruit, unless significant carotid stenosis (e.g. >70%) has been excluded by appropriate investigation
• History of urinary retention
• History of uncontrolled narrow angle glaucoma
• Patients who have a history of a seizure disorder, including alcoholic seizures, a family history of seizures, or a history of head trauma that resulted in loss of consciousness or concussion
• Previous exposure to [S,S]-RBX or racemic reboxetine (Edronax®)
• Any serious or unstable medical conditions that, in the opinion of the investigator, would compromise participation in the trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy of [S,S]-RBX in patients with DPN<br>• To evaluate the safety and tolerability of [S,S]-RBX in patients with DPN;Secondary Objective: ;Primary end point(s): • Daily Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method

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