Diabetic Peripheral Neuropathic Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.
Subjects will be enrolled in the study for a maximum of 43 days, including an optional 14-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day. The primary objective of this study is: - To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control, including emergence of suicidal thoughts. The secondary objectives of this study are: - To evaluate the impact of PG-DN-20WS on subject's neuropathic pain, anxiety, and sleep quality compared to a placebo control. - To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control. ;
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