Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Key facts
- Who runs it
- KAZM Pharmaceuticals Inc.
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 306 people enrolled
- Started
- 9 Sept 2024
- Ended
- 19 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Multiprofen-CC™ plus standard treatment
- Placebo plus standard treatment
- Record updated
- 29 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
Who cannot take part
- Administration of any investigational drug in the period of 0 to 45 days before entry into the study
- Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or lidocaine, any of the study drugs or their ingredients
- Have a history of substance abuse
- Use daily opioids (other than short acting codeine) for a chronic pain condition other than knee OA
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
- Diagnosis of uncontrolled hypertension
- Diagnosis of active peptic ulcer disease
- A history of chronic (> 3 months) anticoagulant usage
- History of impaired kidney or liver function
- Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision
- Pregnancy
- Actively breastfeeding
- Unable to provide informed consent (e.g. cognitive disability)
- Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical treatments as instructed)
- Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA
- Body Mass Index (BMI) > 50kg/m2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Multiprofen-CC™Treatment being tested
Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery
Treatment: Multiprofen-CC™ plus standard treatment
- ControlPlacebo, for comparison
Standard care pain medications and visually identical topical placebo (1g TID) for 6 weeks after surgery
Treatment: Placebo plus standard treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial
- Record updated
- 29 June 2026