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Cannabinoids for Postoperative Pain and Osteoarthritis Following TKA
Phase 3
Recruiting
Led By Anthony Adili, MD, P.Eng
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Awards & highlights
Pivotal Trial
Study Summary
This trial will assess whether adding CBD to usual care before and after surgery can reduce the rate of persistent post-surgical pain after total knee replacement.
Eligible Conditions
- Osteoarthritis of the Knee
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Persistent post-surgical pain (PPSP)
Secondary outcome measures
Anxiety and depression
Insomnia
Mental function
+6 moreOther outcome measures
Feasibility - compliance
Feasibility - recruitment
Feasibility - retention
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MPL-001 (CBD: THC 25:1)Experimental Treatment1 Intervention
125mg CBD/5 mg THC oil for oral use
Group II: PlaceboPlacebo Group1 Intervention
Visually identical placebo (medium chain triglyceride oil)
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationOTHER
361 Previous Clinical Trials
302,716 Total Patients Enrolled
2 Trials studying Osteoarthritis
233 Patients Enrolled for Osteoarthritis
McMaster UniversityLead Sponsor
863 Previous Clinical Trials
2,527,040 Total Patients Enrolled
19 Trials studying Osteoarthritis
901,062 Patients Enrolled for Osteoarthritis
St. Joseph's Healthcare HamiltonOTHER
193 Previous Clinical Trials
25,337 Total Patients Enrolled
1 Trials studying Osteoarthritis
64 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a problem with drugs or alcohol, as defined by doctors using specific criteria.You are allergic or intolerant to cannabis or any ingredients in the study drug.You have previously undergone revision total knee replacement surgery.You have had knee replacement surgery on both knees.You have chronic knee pain that is not caused by osteoarthritis. If your knee pain is due to fibromyalgia or chronic pain syndrome, you will not be eligible for the study.You have a serious heart or lung condition that affects your daily activities and requires constant medical attention.
Research Study Groups:
This trial has the following groups:- Group 1: MPL-001 (CBD: THC 25:1)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA released any guidance on CBD usage?
"There is some evidence that CBD is effective, and it has been studied multiple times, so it received a score of 3."
Answered by AI
Is there precedent for CBD as a medication?
"As of now, 83 clinical trials for Cannabidiol (CBD) are ongoing. Of these, 18 are in Phase 3. The numerous studies for Cannabidiol (CBD) have their origins in Ribeirao Preto, Sao Paulo, but expanded to 311 locations."
Answered by AI
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