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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Knee pain for at least three months, occurring in at least half of the days in that period
Patients presenting with knee osteoarthritis (KL Grade II-III)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 84
Awards & highlights
Study Summary
This trial is testing if CBD ODTs can help treat pain and improve function in people with knee osteoarthritis.
Eligible Conditions
- Knee Arthritis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been experiencing knee pain for at least three months, happening on most days during that time.
Select...
You have moderate to severe knee osteoarthritis.
Select...
You have moderate to severe pain, rated at least 4 out of 10 on a pain scale.
Select...
You have knee osteoarthritis that has been classified as grade II or III according to the Kellgren-Lawrence grading system.
Select...
You are experiencing pain rated 4 or higher on a visual analog scale (VAS).
Select...
You have been experiencing knee pain for at least three months, happening at least half of the time during that period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Knee
Number of Patients Requiring Rescue Corticosteroid Use
Pain
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBD GroupExperimental Treatment1 Intervention
The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day.
Group II: Placebo GroupPlacebo Group1 Intervention
Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol (CBD)
2019
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,335 Previous Clinical Trials
795,016 Total Patients Enrolled
Orcosa Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Michael J Alaia, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate to severe pain, rated at least 4 out of 10 on a pain scale.You have moderate to severe knee osteoarthritis.You have a history of using cannabis excessively or becoming dependent on it.You have significant neurological conditions like memory loss, difficulty moving, trouble thinking, seizures, or a history of serious head injury.You have knee osteoarthritis that has been classified as grade II or III according to the Kellgren-Lawrence grading system.You are experiencing pain rated 4 or higher on a visual analog scale (VAS).You have been experiencing knee pain for at least three months, happening on most days during that time.You have moderate to severe knee osteoarthritis.You are female and you are currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly.You have been taking opioid medications recently for any reason.You have a large buildup of fluid in your body that needs to be drained.You have been diagnosed with severe depression, mental illness, or problems with substance abuse.You currently have thoughts of hurting yourself or have had them in the past.You have received injections in your knee, such as cortisone, platelet-rich plasma (PRP), or hyaluronic acid, in the past 3 months.You have been diagnosed with a major psychiatric illness, like bipolar disorder, according to the DSM-V guidelines.You have had a stroke or heart attack in the past three months.You have been experiencing knee pain for at least three months, and it has been happening on more than half of those days.You have been experiencing knee pain for at least three months, happening at least half of the time during that period.You have a pain score of 4 or higher on a visual scale.
Research Study Groups:
This trial has the following groups:- Group 1: CBD Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Knee Arthritis Patient Testimony for trial: Trial Name: NCT05020028 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have an age limit? At what point do potential participants become too old to be included in the research?
"The age range that this clinical study is recruiting patients starts at 40 years old and finishes at 75 years old."
Answered by AI
Are patients still being accepted into this research program?
"Per the clinicaltrials.gov website, this clinical trial is actively recruiting patients. The study was originally posted on 6/22/2022 and has since been edited on 7/15/2022."
Answered by AI
How can I become a part of this clinical trial?
"This trial is looking for 100 patients that are 40-75 years old and have arthrosis. Other inclusion criteria include: pain in the knee for at least 3 months, a VAS score of 4 or higher, and being pre-menopausal (for female patients). Patients must also be using effective forms of contraception."
Answered by AI
Could you please explain what other research has looked into Cannabidiol (CBD)?
"Right now, 83 different clinical trials are underway for Cannabidiol (CBD). Of these, 18 have progressed to Phase 3. However, the majority of research locations for this treatment are in Ribeirao Preto, Sao Paulo. In total, 311 medical centres are running studies on CBD's efficacy."
Answered by AI
How many individuals are being included in this research project?
"Yes, this is an ongoing study that has updated their information on clinicaltrials.gov as of 7/15/2022. They are looking for 100 individuals to participate at 1 site."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to find a cure!
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- NYU Langone Health: < 48 hours
Average response time
- < 2 Days
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