RecruitingPhase 3NCT06202989

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial


Sponsor

KAZM Pharmaceuticals Inc.

Enrollment

288 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty. Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Multiprofen-CC™ plus standard treatment and Placebo plus standard treatment for people with postsurgical pain. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMultiprofen-CC™ plus standard treatment

Multiprofen-CC™ \[ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)\] Dose: 1.0g, 3 times per day for 6 weeks after surgery

OTHERPlacebo plus standard treatment

The placebo is the base cream with no medicinal ingredients to be applied 3 times per day for 6 weeks after surgery


Locations(2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Oakville Trafalgar Memorial Hospital

Oakville, Ontario, Canada

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NCT06202989


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