NCT04992962

Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee

A Double-Blind, Randomized, Placebo-Controlled, Three-Arm Trial Examining Sublingual Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Pure Green · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	CBD/CBN	A water-soluble sublingual tablet containing 10 mg of CBD and 10 mg of CBN.
DRUG	CBD/THC	A water-soluble sublingual tablet containing 10 mg of CBD and 5 mg of THC.
DRUG	Placebo	An inactive compound.

Timeline

• Start date: 2021-07-29
• Primary completion: 2021-10-30
• Completion: 2021-11-14
• First posted: 2021-08-06
• Last updated: 2021-08-06

Locations

1 site across 1 country: United States