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Cannabinoids for Postoperative Pain and Osteoarthritis Following TKA

Phase 3
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
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


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months for reporting.

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
Mental function
+6 more
Other 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

MPL-001 (CBD: THC 25:1) Clinical Trial Eligibility Overview. Trial Name: NCT03825965 — Phase 3
Osteoarthritis Research Study Groups: MPL-001 (CBD: THC 25:1), Placebo
Osteoarthritis Clinical Trial 2023: MPL-001 (CBD: THC 25:1) Highlights & Side Effects. Trial Name: NCT03825965 — Phase 3
MPL-001 (CBD: THC 25:1) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03825965 — Phase 3

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
~23 spots leftby Aug 2024