Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet

Study Overview
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Brief Summary
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This study is a prospective Phase 2, drug controlled, open-label study to evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain associated with osteoarthritis of the knee.

Official Title
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Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet

Conditions
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Osteoarthritis, Knee, Pain

Intervention / Treatment
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* Drug: Test Article


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 21 years of age; Subject has a diagnosis of a pain related to osteoarthritis of the knee as determined by the subject's primary care physician or related health care provider. Subject has a mean pain scale score of ≥ 4 recorded in the 7 days prior to enrollment. If female, the subject is postmenopausal (> 1 year), surgically sterile (> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control. Subject has not taken marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and promises to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study. Subject has not taken any pain medication, including NSAIDs, for at least 2 days before taking the first dose of study drug. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document. Subject is willing to use an electronic diary to enter a pain scale score up to four times a day for 28 days. Exclusion Criteria Subject is pregnant or lactating; Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes; Subject has a known allergy to active or inert ingredients of PG-OA-10:10-2020-B tablets; Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS)); Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and does not promise that they will not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study; Subject is currently being treated with antibiotics for sinus, throat, or lung infections; Subject has shortness of breath associated with allergies; Subject has uncontrolled asthma; Subject has a fever and/or productive cough; Subject has unstable angina, uncontrolled hypertension; Subject currently or has a history of congestive heart failure; Subject has any other unstable medical condition; Subject has a personal or family history of schizophrenia; Subject has a personal history or currently has suicidal ideation or attempted suicide; Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. Subject has taken pain medicine of any kind throughout the screening period, or has taken acetaminophen within 2 days of taking the first dose of study drug. Subject has an allergy to, or has an intolerance to, acetaminophen. Subject is currently taking any form of opioids. Subject has a history of alcohol or substance abuse Subject has clinically significant illness, including cardiovascular disorders. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pure Green Sublingual Tablet - Daily<br>Subjects will take 2 tablets daily, one in the morning and one in the evening, and are able to take up to 2 additional tablets per day as needed for pain. | Drug: Test Article<br>* 10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score. | To evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain due to osteoarthritis of the knee by having patients evaluate their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 4. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients. | To evaluate the impact of Pure Green sublingual tablets on the general health and well-being of osteoarthritis of the knee patiens. The objective is to examine quality of life metrics: overall quality of life and general health, physical health, and knee pain as measured on a 1-5 scale before and after the study | 30 Days | 
| Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee. | The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green sublingual tablet study on sleep changes. Patients will be asked questions before beginning of the study and after completion. | 30 Days | 
| Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee | The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green sublingual tablets on anxiety in patients with osteoarthritis of the knee. The scale of 0-4 will be used where 0 is no anxiety present and 4 is very severe anxiety. | 30 Days | 
| Impact on the use of sublingual tablets as the route of administration. | To explore the impact of sublingual administration on patient compliance by evaluating the number of tablets taken per day as entered by the patients into the smart phone app. | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD, THC, Cannabidiol, Tetrahydrocannabinol, Osteoarthritis, Knee, Pain