Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy (NCT03664921) | Clinical Trial Compass
CompletedPhase 2
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
United States55 participantsStarted 2018-11-15
Plain-language summary
This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female between the ages of 18 and 75 years of age.
✓. Diabetes mellitus diagnosis for at least 6 months.
✓. Total glycosylated hemoglobin of \<=12%.
✓. Antidiabetic therapy used at screening will not be changed during the study.
✓. Clinical diagnosis, confirmed by the Investigator, of painful diabetic neuropathy with symptoms and signs for at least 6 months.
✓. Lower extremity pain, from diabetic neuropathy, present daily for the previous 3 months.
✓. Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to \<=160mg of oral morphine.
✓. Average neuropathic pain intensity over last 3 days before randomization (Segment 1, Study Day 1) of at least 4 on a 0-10 scale (0 = no pain; 10 = the worst possible pain).
Exclusion criteria
✕. Clinically significant abnormal vital signs including oral temperature \> 38°C or history of current illness.
✕. Inability to exclude other causes of polyneuropathy including: alcoholism, vitamin B12 deficiency, endocrinopathies, vasculitides, heavy metal exposure, drug use, and malignancy (direct or paraneoplastic).
✕. History of seizures, epilepsy, or recognized increase risk of seizure (e.g. head trauma, metabolic disorders, alcohol and drug withdrawal).
✕. History of cirrhosis or laboratory evidence of liver disease.
✕. 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.
✕. History of previous anaphylaxis, severe allergic reaction to tramadol, codeine or other opioid drugs.
✕. Contraindication to use of opioids, tramadol, or acetaminophen.