Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of painful DPN. Generally, the available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to DPN for least 6 months and no greater than 5 years. Patients will be recruited after providing written informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
1 BD for 28 days
1 BD for 28 Days
Matching Placebo for 28 Days
Site 2
Mainz, Germany
Site 1
Manchester, United Kingdom
Mean 24-hour average pain intensity (API) score
Time frame: 4 weeks
Mean night-time API Score
Time frame: 4 weeks
Patient Global Impression of Change
Time frame: 4 weeks
Clinician Global Impression of Change
Time frame: 4 weeks
Adverse events (AE)
Time frame: 4 weeks
Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.