Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

Exclusion Criteria

• •1. Clinically significant abnormal vital signs including oral temperature \> 38°C or history of current illness.
• •2. Inability to exclude other causes of polyneuropathy including: alcoholism, vitamin B12 deficiency, endocrinopathies, vasculitides, heavy metal exposure, drug use, and malignancy (direct or paraneoplastic).
• •3. History of seizures, epilepsy, or recognized increase risk of seizure (e.g. head trauma, metabolic disorders, alcohol and drug withdrawal).
• •4. History of cirrhosis or laboratory evidence of liver disease.
• •5. Use of serotonergic drugs and drugs that impair serotonin metabolism (e.g., mirtazapine, trazodone); monoamine oxidase inhibitors, including linezolid, methylene blue; serotonin and norepinephrine reuptake inhibitors, except fluoxetine, within 14 days of Segment 1, Study Day 1 or during the study, use of fluoxetine within 28 days of Segment 1, Study Day 1, or during the study; and selective serotonin re-uptake inhibitors. Use of tricyclic antidepressants and other tricyclic drugs including cyclobenzaprine and promethazine; triptans; 5-HT3 receptor antagonists; neuroleptics. Use of benzodiazepines or other central nervous system depressants including non-benzodiazepine sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics within 14 days of Segment 1, Study Day 1, or during the study. Use of opiates, including tramadol, within 28 days of Segment 1, Study Day 1, or during the study. Use of all other analgesics, except acetaminophen, within 14 days of Segment 1, Study Day 1, or during the study.
• •6. History of previous anaphylaxis, severe allergic reaction to tramadol, codeine or other opioid drugs.
• •7. Contraindication to use of opioids, tramadol, or acetaminophen.
• •8. Use of non-pharmacological pain therapy.
• •9. Any other unstable acute or chronic disease that could interfere with the evaluation of the safety of the study drug as determined by the principal Investigator in dialogue with the Sponsor's Medical Monitor.
• •10. Currently pregnant or breast-feeding a child.
• •11. Unlikely to comply with the study protocol.
• •12. Known or suspected alcohol or drug abuse within the past 12 months.
• •13. Received another investigational agent within 4 weeks before screening visit, or receiving any other investigational agent during this study.
• •14. Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.