Painful Diabetic Neuropathy Clinical Trial
Official title:
A Phase II, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients With Painful Diabetic Neuropathy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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