Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Last updated: November 12, 2024
Sponsor: KAZM Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Multiprofen-CC™ plus standard treatment

Placebo plus standard treatment

Clinical Study ID

NCT06202989
PR-001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adults (18+)

  • Undergoing Primary Elective TKA

  • Provide informed consent

Exclusion

Exclusion Criteria:

  • Administration of any investigational drug in the period of 0 to 45 days beforeentry into the study

  • 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 topicaltreatments as instructed)

  • Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, orlidocaine, 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 conditionother than knee OA

  • Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA

  • Any other condition which, in the opinion of the investigators, is likely tointerfere 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 thesurgical incision

  • Body Mass Index (BMI) > 50kg/m2

Study Design

Total Participants: 288
Treatment Group(s): 2
Primary Treatment: Multiprofen-CC™ plus standard treatment
Phase: 3
Study Start date:
September 09, 2024
Estimated Completion Date:
April 01, 2026

Study Description

Total knee replacement, also known as total knee arthroplasty (TKA), is a surgical procedure aimed at alleviating pain and improving joint function in individuals with severe knee joint damage, often caused by conditions like osteoarthritis (OA) While TKAs generally yield positive results, a significant amount of patients express dissatisfaction with their outcomes, with some continuing to experience persistent pain after surgery. Opioids are very commonly prescribed for postsurgical pan, but they can cause a host of unwanted side effects. Orthopaedic surgeons prescribe opioids more frequently than in any other surgical speciality. This is a rising concern to the healthcare system as it may promote the development of opioid use disorder. There is a need for alternative therapies to opioid prescribing in patients having knee surgery to reduce the extensive health risks associated with opioid medications.

Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%). Healthcare professionals have the option to prescribe it to patients who are encountering localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in OA patients although there is compelling evidence that its medicinal ingredients are effective in pain relief.

The aim of the proposed study is to determine if, in patients with end-stage knee OA undergoing TKA, the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in reducing acute post-operative pain during a 6 week follow-up period. Secondary objectives include determining the effects of Multiprofen-CC™ compared to placebo on opioid use, satisfaction with pain management, and we will also identify adverse events.

Connect with a study center

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Oakville Trafalgar Memorial Hospital

    Oakville, Ontario L6M 0L8
    Canada

    Site Not Available

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