Osteoarthritis, KneePhase 2NCT04195269
Osteoarthritis of the Knee Pain Study Using a CBD and THC Sublingual Tablet
A Phase 2 study testing Test Article in people with Osteoarthritis, Knee and Pain, run by Pure Green at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- Test Article
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 15 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pure Green, LLC
West Bloomfield, Michigan, 48323
Matthew Caloura, 248-802-4380, mcaloura@pure.green
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- Test Article
- Keywords
- CBD, THC, Cannabidiol, Tetrahydrocannabinol, Osteoarthritis, Knee, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ArticleDrug
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Test Article |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 Apr 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pure Green
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Kimless, M.D., Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195269
- Sponsor's protocol ID
- PG-OA-1010-19-004
- Status last verified
- Apr 2020
- First submitted
- 9 Dec 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24294303Blake 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.
PubMed 16282192Australian 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.
PubMed 29635215Huggins 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.
PubMed 22727500Fukuda 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.
PubMed 25115332Krustev 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.
PubMed 25260980Smith 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.
PubMed 9610941Schuelert 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.
PubMed 18163511Schuelert 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.
PubMed 21185649Richardson 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.
PubMed 18416822
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarthritis of the Knee Pain Study Using CBD and THC in Rapidly Dissolvable Sublingual Tablet
- ClinicalTrials.gov ID
- NCT04195269
- Acronym / sponsor ID
- PG-OA-1010-19-004
- Conditions
- Osteoarthritis, Knee, Pain
- Keywords
- CBD, THC, Cannabidiol, Tetrahydrocannabinol, Osteoarthritis, Knee, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pure GreenIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pure Green Sublingual Tablet - Daily | Experimental | Drug: Test ArticleSubjects 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Article10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes. | Drug | Pure Green Sublingual Tablet - Daily |
Primary outcome
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.
4 secondary outcomes
Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients.
Time frame: 30 Days
Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee.
Time frame: 30 Days
Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee
Time frame: 30 Days
Impact on the use of sublingual tablets as the route of administration.
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 24294303Brown 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.
- Background: PubMed 16282192Blake 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.
- BackgroundAustralian Public Assessment Report for Nabiximols
- Background: PubMed 29635215O'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.
- Background: PubMed 22727500Huggins 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.
- Background: PubMed 25115332Fukuda 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.
- Background: PubMed 25260980Krustev 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.
- Background: PubMed 9610941Smith 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.
- Background: PubMed 18163511Schuelert 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.
- Background: PubMed 21185649Schuelert 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.
- Background: PubMed 18416822Richardson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kimless, M.D. principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Test Article in people with Osteoarthritis, Knee and Pain, run by Pure Green at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Caloura, C.C.R.P. ((248) 802-4380, mcaloura@pure.green), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195269, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.