NCT04992962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 29, 2021

Last Update Submit

July 29, 2021

Conditions

Osteoarthritis, Knee

Keywords

CBDCannabidiolCBNCannabinolTHCOsteoarthritisPainPlacebo

Outcome Measures

Primary Outcomes (2)

  • Pain as assessed by Numerical Pain Rating Scale (NPRS)

    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)

    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 Outcomes (1)

  • Incidence of treatment-related adverse events as assessed by CTCAE v4.0.

    28 Days

Study Arms (3)

CBD/CBN

EXPERIMENTAL

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

CBD/THC

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

A placebo sublingual tablet to be taken three times a day for 28 days

Drug: Placebo

Interventions

CBD/CBNDRUG

A water-soluble sublingual tablet containing 10 mg of CBD and 10 mg of CBN.

CBD/CBN
CBD/THCDRUG

A water-soluble sublingual tablet containing 10 mg of CBD and 5 mg of THC.

CBD/THC
PlaceboDRUG

An inactive compound.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is at least 21 years of age;
  • Subject has a diagnosis of osteoarthritis of the knee as determined by the subject's primary care physician or related health care provider.
  • Subject reports an average NPRS score of ≥ 5 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 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.
  • 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.
  • Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to starting study treatment.
  • 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 trial information for 29 days.

You may not qualify if:

  • 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 the investigational product;
  • 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;
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pure Green Pharmaceuticals

West Bloomfield, Michigan, 48323, United States

RECRUITING

Related Publications (13)

  • Papaleontiou M, Henderson CR Jr, Turner BJ, Moore AA, Olkhovskaya Y, Amanfo L, Reid MC. Outcomes associated with opioid use in the treatment of chronic noncancer pain in older adults: a systematic review and meta-analysis. J Am Geriatr Soc. 2010 Jul;58(7):1353-69. doi: 10.1111/j.1532-5415.2010.02920.x. Epub 2010 Jun 1.

    PMID: 20533971BACKGROUND

  • Eli Lilly & Company. (2019). Cymbalta: Highlights of prescribing information. Indianapolis, IN.

    BACKGROUND

  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PMID: 20699159BACKGROUND

  • 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.

    BACKGROUND

  • Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

    PMID: 28033313BACKGROUND

  • Frakes EP, Risser RC, Ball TD, Hochberg MC, Wohlreich MM. Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: results of a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 Dec;27(12):2361-72. doi: 10.1185/03007995.2011.633502. Epub 2011 Nov 9.

    PMID: 22017192BACKGROUND

  • Blake 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.

    PMID: 16282192BACKGROUND

  • Wang T, Collet JP, Shapiro S, Ware MA. Adverse effects of medical cannabinoids: a systematic review. CMAJ. 2008 Jun 17;178(13):1669-78. doi: 10.1503/cmaj.071178.

    PMID: 18559804BACKGROUND

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PMID: 11690728BACKGROUND

  • Michener LA, Snyder AR, Leggin BG. Responsiveness of the numeric pain rating scale in patients with shoulder pain and the effect of surgical status. J Sport Rehabil. 2011 Feb;20(1):115-28. doi: 10.1123/jsr.20.1.115.

    PMID: 21411827BACKGROUND

  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PMID: 15928561BACKGROUND

  • Ogura T, Ackermann J, Mestriner AB, Merkely G, Gomoll AH. The Minimal Clinically Important Difference and Substantial Clinical Benefit in the Patient-Reported Outcome Measures of Patients Undergoing Osteochondral Allograft Transplantation in the Knee. Cartilage. 2021 Jan;12(1):42-50. doi: 10.1177/1947603518812552. Epub 2018 Nov 22.

    PMID: 30463426BACKGROUND

  • Jacquet C, Pioger C, Khakha R, Steltzlen C, Kley K, Pujol N, Ollivier M. Evaluation of the "Minimal Clinically Important Difference" (MCID) of the KOOS, KSS and SF-12 scores after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):820-826. doi: 10.1007/s00167-020-06026-0. Epub 2020 Apr 27.

    PMID: 32342141BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra Kimless, M.D.

    Pure Green Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Caloura

CONTACT

(248) 802-4380mcaloura@pgpharma.co

Debra Kimless, M.D.

CONTACT

(248) 920-8761dkimlessmd@pgpharma.co

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 6, 2021

Study Start

July 29, 2021

Primary Completion

October 30, 2021

Study Completion

November 14, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)