Clinical trial NCT04992962: Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee
Official title: A Double-Blind, Randomized, Placebo-Controlled, Three-Arm Trial Examining Sublingual Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: CBD
Cannabidiol
CBN
Cannabinol
THC
Osteoarthritis
Pain
Placebo
Lead sponsor: Pure Green
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of PG-OA-10CN and PG-OA-5TH tablets as a better pain reliever in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo.

Detailed description: Subjects will be enrolled in the study for a maximum of 36 days, including a 7-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day.

The primary objective of this study is:

* To evaluate the efficacy of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee, compared to a placebo control.

The secondary objectives of this study are:

* To evaluate differences of efficacy between PG-OA-10CN and PG-OA-5TH
* To evaluate the impact of PG-OA-10CN and PG-OA-5TH for stiffness, function in daily living, function in sport and recreation, and knee related quality of life as assessed by the KOOS.
* To evaluate the safety of PG-OA-10CN and PG-OA-5TH for the treatment of pain associated with osteoarthritis of the knee.

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 21 years of age;
2. Subject has a diagnosis of osteoarthritis of the knee as determined by the subject's primary care physician or related health care provider.
3. Subject reports an average NPRS score of ≥ 5 in the 7 days prior to enrollment.
4. 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.
5. 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 agrees 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.
6. If subject is currently taking a prohibited medication, subject must be willing to and complete a washout of these medications during the screening period and prior to starting study treatment.
7. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to starting study treatment.
8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
9. Subject is willing to use an electronic diary to enter trial information for 29 days.

Exclusion Criteria:

1. Subject is pregnant or lactating;
2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
3. Subject has a known allergy to active or inert ingredients of the investigational product;
4. 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));
5. 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;
6. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
7. Subject has shortness of breath associated with allergies;
8. Subject has uncontrolled asthma;
9. Subject has a fever and/or productive cough;
10. Subject has unstable angina, uncontrolled hypertension;
11. Subject currently or has a history of congestive heart failure;
12. Subject has any other unstable medical condition;
13. Subject has a personal or family history of schizophrenia;
14. Subject has a personal history or currently has suicidal ideation or attempted suicide;
15. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
16. Subject has taken pharmaceutical pain medicine, including OTC pain medicine of any kind, or has taken a NSAID and/or acetaminophen within 2 days of starting study treatment.
17. Subject has taken a prohibited medication during the screening period and prior to starting study treatment or is unwilling to stop these medications.
18. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen.
19. Subject has taken any form of steroids, including a local steroid injection in the knee, within 1 month of starting study treatment.
20. Subject has received any invasive interventions or surgery of the knee.
21. Subject has a history of substance or alcohol abuse.
22. Subject has clinically significant illness, including cardiovascular disorders.
23. 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.
24. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Primary outcomes:
measure: Pain as assessed by Numerical Pain Rating Scale (NPRS)
timeFrame: 28 Days
measure: Pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 28 Days
Secondary outcomes:
measure: Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 28 Days
Other outcomes:
Locations:
city: West Bloomfield
country: United States
facility: Pure Green Pharmaceuticals
state: Michigan
Study officials:
affiliation: Pure Green Pharmaceuticals
name: Debra Kimless, M.D.
role: PRINCIPAL_INVESTIGATOR
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