- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195269
Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet
April 10, 2020 updated by: Pure Green
Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Caloura, C.C.R.P.
- Phone Number: (248) 802-4380
- Email: mcaloura@pure.green
Study Locations
-
-
Michigan
-
West Bloomfield, Michigan, United States, 48323
- Recruiting
- Pure Green, LLC
-
Contact:
- Matthew Caloura
- Phone Number: 248-802-4380
- Email: mcaloura@pure.green
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
|
What is the study measuring?
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.
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.
|
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.
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
|
30 Days
|
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.
|
30 Days
|
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.
|
30 Days
|
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.
|
30 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debra Kimless, M.D., Chief Medical Officer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Blake DR, Robson P, Ho M, Jubb RW, McCabe CS. Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology (Oxford). 2006 Jan;45(1):50-2. doi: 10.1093/rheumatology/kei183. Epub 2005 Nov 9.
- Brown JP, Boulay LJ. Clinical experience with duloxetine in the management of chronic musculoskeletal pain. A focus on osteoarthritis of the knee. Ther Adv Musculoskelet Dis. 2013 Dec;5(6):291-304. doi: 10.1177/1759720X13508508.
- Australian Public Assessment Report for Nabiximols
- O'Brien M, McDougall JJ. Cannabis and joints: scientific evidence for the alleviation of osteoarthritis pain by cannabinoids. Curr Opin Pharmacol. 2018 Jun;40:104-109. doi: 10.1016/j.coph.2018.03.012. Epub 2018 Apr 7.
- Huggins JP, Smart TS, Langman S, Taylor L, Young T. An efficient randomised, placebo-controlled clinical trial with the irreversible fatty acid amide hydrolase-1 inhibitor PF-04457845, which modulates endocannabinoids but fails to induce effective analgesia in patients with pain due to osteoarthritis of the knee. Pain. 2012 Sep;153(9):1837-1846. doi: 10.1016/j.pain.2012.04.020. Epub 2012 Jun 21.
- Fukuda S, Kohsaka H, Takayasu A, Yokoyama W, Miyabe C, Miyabe Y, Harigai M, Miyasaka N, Nanki T. Cannabinoid receptor 2 as a potential therapeutic target in rheumatoid arthritis. BMC Musculoskelet Disord. 2014 Aug 12;15:275. doi: 10.1186/1471-2474-15-275.
- Krustev E, Reid A, McDougall JJ. Tapping into the endocannabinoid system to ameliorate acute inflammatory flares and associated pain in mouse knee joints. Arthritis Res Ther. 2014 Sep 27;16(5):437. doi: 10.1186/s13075-014-0437-9.
- Smith FL, Fujimori K, Lowe J, Welch SP. Characterization of delta9-tetrahydrocannabinol and anandamide antinociception in nonarthritic and arthritic rats. Pharmacol Biochem Behav. 1998 May;60(1):183-91. doi: 10.1016/s0091-3057(97)00583-2.
- Schuelert N, McDougall JJ. Cannabinoid-mediated antinociception is enhanced in rat osteoarthritic knees. Arthritis Rheum. 2008 Jan;58(1):145-53. doi: 10.1002/art.23156.
- Schuelert N, Johnson MP, Oskins JL, Jassal K, Chambers MG, McDougall JJ. Local application of the endocannabinoid hydrolysis inhibitor URB597 reduces nociception in spontaneous and chemically induced models of osteoarthritis. Pain. 2011 May;152(5):975-981. doi: 10.1016/j.pain.2010.11.025. Epub 2010 Dec 24.
- Richardson D, Pearson RG, Kurian N, Latif ML, Garle MJ, Barrett DA, Kendall DA, Scammell BE, Reeve AJ, Chapman V. Characterisation of the cannabinoid receptor system in synovial tissue and fluid in patients with osteoarthritis and rheumatoid arthritis. Arthritis Res Ther. 2008;10(2):R43. doi: 10.1186/ar2401. Epub 2008 Apr 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 20, 2020
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
July 15, 2020
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (Actual)
December 11, 2019
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PG-OA-1010-19-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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