Osteoarthritis, Knee Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled, Three-Arm Trial Examining Sublingual Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee.
The purpose of the study is to evaluate the efficacy of PG-OA-10CN and PG-OA-5TH tablets as a better pain reliever in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo.
Subjects will be enrolled in the study for a maximum of 36 days, including a 7-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 efficacy of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee, compared to a placebo control. The secondary objectives of this study are: - To evaluate differences of efficacy between PG-OA-10CN and PG-OA-5TH - To evaluate the impact of PG-OA-10CN and PG-OA-5TH for stiffness, function in daily living, function in sport and recreation, and knee related quality of life as assessed by the KOOS. - To evaluate the safety of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee. ;
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