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

NCT04195269 | Unknown Phase 2 DMC

• 1 other identifier: PG-OA-1010-19-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Pain

Keywords

CBD; THC; Cannabidiol; Tetrahydrocannabinol; Osteoarthritis; Knee; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients.

  30 Days

• Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee.

  30 Days

• Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee

  30 Days

• Impact on the use of sublingual tablets as the route of administration.

  30 Days

Study Arms (1)

Pure Green Sublingual Tablet - Daily

EXPERIMENTAL

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

Interventions

Test Article DRUG

10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.

Pure Green Sublingual Tablet - Daily

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pure Green: lead

Study Sites (1)

Pure Green, LLC

West Bloomfield, Michigan, 48323, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 24294303 BACKGROUND

• 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.

  PMID: 16282192 BACKGROUND

• Australian Public Assessment Report for Nabiximols

  BACKGROUND

• 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.

  PMID: 29635215 BACKGROUND

• 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.

  PMID: 22727500 BACKGROUND

• 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.

  PMID: 25115332 BACKGROUND

• 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.

  PMID: 25260980 BACKGROUND

• 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.

  PMID: 9610941 BACKGROUND

• 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.

  PMID: 18163511 BACKGROUND

• 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.

  PMID: 21185649 BACKGROUND

• 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.

  PMID: 18416822 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra Kimless, M.D.

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Caloura, C.C.R.P.

CONTACT

(248) 802-4380; mcaloura@pure.green

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: April 20, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 15, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)