Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

NCT06202989 | Recruiting Phase 3

• 1 other identifier: PR-001
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postsurgical Pain

Keywords

Osteoarthritis, Knee; Arthroplasty, Replacement, Knee; Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• Acute postoperative pain

  Daily pain score on 0-10 numeric rating scale from post-op day 1 up to 6-weeks postop.

  1, 2, 3, 4, 5, and 6 weeks postop

Secondary Outcomes (4)

• Time to opioid cessation

  6 weeks postop

• Satisfaction with Pain Management

  6 weeks postop

• Safety - Adverse events

  up to 6 weeks postop

• Cumulative opioid use measured in Morphine Equivalent Dose (MED)

  up to 6 weeks postop

Study Arms (2)

Multiprofen-CC™

EXPERIMENTAL

Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery

Drug: Multiprofen-CC™ plus standard treatment

Control

PLACEBO COMPARATOR

Standard care pain medications and visually identical topical placebo (1g TID) for 6 weeks after surgery

Other: Placebo plus standard treatment

Interventions

Multiprofen-CC™ plus standard treatment DRUG

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

Multiprofen-CC™

Placebo plus standard treatment OTHER

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

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18+)
• Undergoing Primary Elective TKA
• Provide informed consent

You may not qualify if:

• Administration of any investigational drug in the period of 0 to 45 days before entry 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 topical treatments as instructed)
• 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
• 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 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

Sponsors & Collaborators

• KAZM Pharmaceuticals Inc.: lead
• McMaster University: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Oakville Trafalgar Memorial Hospital

Oakville, Ontario, L6M 0L8, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Giuseppe Valente, MD, MMgt, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breanne Flood, MSc

CONTACT

905-870-1382; floodbl@mcmaster.ca

Kim Irish, BSW

CONTACT

365-336-7598; irishkd@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All included patients, research personnel, healthcare providers and outcome assessors will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-arm parallel group randomized placebo-controlled trial

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 12, 2024
• Study Start: September 9, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (2)