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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04992962
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pure Green

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: CBD/CBN Drug: CBD/THC Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 29, 2021
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : November 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: CBD/CBN
Participants will receive a 28-day supply of CBD/CBN sublingual tablets to be taken 3 times a day for 28 days.
Drug: CBD/CBN
A water-soluble sublingual tablet containing 10 mg of CBD and 10 mg of CBN.

Experimental: CBD/THC
Participants will receive a 28-day supply of CBD/THC sublingual tablets to be taken 3 times a day for 28 days.
Drug: CBD/THC
A water-soluble sublingual tablet containing 10 mg of CBD and 5 mg of THC.

Placebo Comparator: Placebo
A placebo sublingual tablet to be taken three times a day for 28 days
Drug: Placebo
An inactive compound.




Primary Outcome Measures :
  1. Pain as assessed by Numerical Pain Rating Scale (NPRS) [ Time Frame: 28 Days ]
    To evaluate the impact of PG-OA-10CN and PG-OA-10TC on the subject's osteoarthritis of the knee pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain and lower scores indicate less pain reported by the subject.

  2. Pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 28 Days ]
    To evaluate the impact of PG-OA-10CN and PG-OA-10TC on the subject's osteoarthritis of the knee pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS is scored from 0-100, where 0 represents extreme problems and 100 represents no problems, as reported by the subject.


Secondary Outcome Measures :
  1. Incidence of treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 28 Days ]
    To evaluate the safety of PG-OA-10CN and PG-OA-10TC for the treatment of pain associated with osteoarthritis of the knee compared to a placebo control assessed by Common Terminology Criteria For Adverse Events (CTCAE) v4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992962


Contacts
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Contact: Matthew Caloura (248) 802-4380 mcaloura@pgpharma.co
Contact: Debra Kimless, M.D. (248) 920-8761 dkimlessmd@pgpharma.co

Locations
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United States, Michigan
Pure Green Pharmaceuticals Recruiting
West Bloomfield, Michigan, United States, 48323
Contact: Matthew Caloura    248-802-4380    mcaloura@pgpharma.co   
Contact: Debra Kimless, M.D.    (248) 920-8761    dkimlessmd@pgpharma.co   
Principal Investigator: Debra Kimless, M.D.         
Sponsors and Collaborators
Pure Green
Investigators
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Principal Investigator: Debra Kimless, M.D. Pure Green Pharmaceuticals
Publications:
Eli Lilly & Company. (2019). Cymbalta: Highlights of prescribing information. Indianapolis, IN.
Ahrnsbrak, R., Bose, J., Hedden, S. L., Lipari, R. N., & Park-Lee, E. (2017). Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, 1572.

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Responsible Party: Pure Green
ClinicalTrials.gov Identifier: NCT04992962    
Other Study ID Numbers: PG-OA-2021
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pure Green:
CBD
Cannabidiol
CBN
Cannabinol
THC
Osteoarthritis
Pain
Placebo
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases