Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet
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|ClinicalTrials.gov Identifier: NCT04195269|
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Pain||Drug: Test Article||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet|
|Estimated Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Experimental: Pure Green Sublingual Tablet - Daily
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
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
- Impact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score. [ Time Frame: 30 days ]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.
- Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients. [ Time Frame: 30 Days ]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
- Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee. [ Time Frame: 30 Days ]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.
- Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee [ Time Frame: 30 Days ]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.
- Impact on the use of sublingual tablets as the route of administration. [ Time Frame: 30 Days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195269
|Contact: Matthew Caloura, C.C.R.P.||(248) email@example.com|
|United States, Michigan|
|Pure Green, LLC||Recruiting|
|West Bloomfield, Michigan, United States, 48323|
|Contact: Matthew Caloura 248-802-4380 firstname.lastname@example.org|
|Principal Investigator:||Debra Kimless, M.D.||Chief Medical Officer|