Postsurgical PainPhase 3MP-TKANCT06202989
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
A Phase 3 study testing Multiprofen-CC™ plus standard treatment in people with Postsurgical Pain, run by KAZM Pharmaceuticals Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain
- What is being tested?
- Multiprofen-CC™ plus standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2024to 19 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
Who cannot join
- 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
Show all 16Show fewer
- 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
- Body Mass Index (BMI) > 50kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Postsurgical Pain
- Being tested
- Multiprofen-CC™ plus standard treatment, Placebo plus standard treatment
- Keywords
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee, Analgesics, Opioid
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofen-CC™ plus standard treatmentDrug
Multiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 6 weeks after surgery
Placebo plus standard treatmentOther
Also called Placebo
The placebo is the base cream with no medicinal ingredients to be applied 3 times per day for 6 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Multiprofen-CC™ | Experimental | Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery Receives: 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 Receives: Other: Placebo plus standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain
Daily pain score on 0-10 numeric rating scale from postop day 1 up to 6 weeks postop.
Measured: 1, 2, 3, 4, 5, and 6 weeks postop
Secondary outcomes (5)
Time to opioid cessation
Use of opioids at 6 weeks postop and timing of opioid cessation.
Measured: 6 weeks postop
Cumulative opioid use measured in Morphine Equivalent Dose (MED)
Cumulative opioid use up to 6 weeks postop measured in MED
Measured: up to 6 weeks postop
Weekly Opioid Use
Weekly opioid use over 6 weeks postop, measured as total MED per postoperative week derived from the daily medication diary.
Measured: 6 weeks postop
Satisfaction with Pain Management
Satisfaction with pain management measured on a 0-10 numeric rating scale (NRS; higher score is better).
Measured: 6 weeks postop
Safety - Adverse events
Knee-related, surgery-related, and IP or pain medication related AEs, plus all SAEs for 6 weeks postop.
Measured: up to 6 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start9 Sep 2024
- Primary completion5 May 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel group randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAZM Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Giuseppe Valente, MD, MMgt, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202989
- Sponsor's protocol ID
- PR-001
- Acronym
- MP-TKA
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06202989
- Acronym / sponsor ID
- MP-TKA / PR-001
- Conditions
- Postsurgical Pain
- Keywords
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee, Analgesics, Opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- KAZM Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel group randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multiprofen-CC™ | Experimental | Drug: Multiprofen-CC™ plus standard treatmentStandard care pain medications and topical Multiprofen-CC™ (1g TID) for 6 weeks after surgery |
| Control | Placebo comparator | Other: Placebo plus standard treatmentStandard care pain medications and visually identical topical placebo (1g TID) for 6 weeks after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiprofen-CC™ plus standard treatmentMultiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 6 weeks after surgery | Drug | Multiprofen-CC™ |
| Placebo plus standard treatmentAlso: PlaceboThe placebo is the base cream with no medicinal ingredients to be applied 3 times per day for 6 weeks after surgery | Other | Control |
Primary outcome
Acute postoperative pain
Time frame: 1, 2, 3, 4, 5, and 6 weeks postop
Daily pain score on 0-10 numeric rating scale from postop day 1 up to 6 weeks postop.
5 secondary outcomes
Time to opioid cessation
Time frame: 6 weeks postop
Cumulative opioid use measured in Morphine Equivalent Dose (MED)
Time frame: up to 6 weeks postop
Weekly Opioid Use
Time frame: 6 weeks postop
Satisfaction with Pain Management
Time frame: 6 weeks postop
Safety - Adverse events
Time frame: up to 6 weeks postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Valente, MD, MMgt, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multiprofen-CC™ plus standard treatment in people with Postsurgical Pain, run by KAZM Pharmaceuticals Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain (time frame: 1, 2, 3, 4, 5, and 6 weeks postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.