Overview

Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee

Status:
Recruiting
Trial end date:
2021-11-14
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pure Green
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.