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

July 29, 2021 updated by: Pure Green

A Double-Blind, Randomized, Placebo-Controlled, Three-Arm Trial Examining Sublingual Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • West Bloomfield, Michigan, United States, 48323
        • Recruiting
        • Pure Green Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 Days
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.
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pure Green

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

November 14, 2021

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG-OA-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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