Multiprofen-CC™ for Postoperative Pain

Recruiting at 1 trial location

Overseen By Kim Madden, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: KAZM Pharmaceuticals Inc.

Must not be taking: Opioids, Anticoagulants, NSAIDs, others

Disqualifiers: Pregnancy, Substance abuse, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a topical pain cream, Multiprofen-CC™, can reduce knee pain and the need for opioids after knee replacement surgery. It focuses on patients with severe knee osteoarthritis undergoing knee replacements, comparing the effects of Multiprofen-CC™ plus regular pain care against a placebo cream plus regular care. This trial may suit individuals having knee replacement surgery due to severe arthritis who haven't recently used experimental drugs. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used any investigational drugs in the last 45 days or if you use daily opioids for chronic pain other than knee osteoarthritis. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Multiprofen-CC™ is a topical cream containing active ingredients such as ketoprofen, baclofen, amitriptyline, and lidocaine. These ingredients commonly help reduce pain and swelling. The cream is available by prescription for muscle and joint pain in specific areas.

Multiprofen-CC™ is in a Phase 3 trial, indicating it has passed earlier safety tests and is generally safe for humans. However, specific results from this trial might not be available yet. The cream's well-known ingredients have been safely used in other treatments, suggesting a low risk of serious side effects.

Consult a healthcare provider with any concerns or questions about joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for postoperative pain that often involve oral medications like opioids or NSAIDs, Multiprofen-CC™ offers a unique approach by using a topical application. This treatment combines standard care medications with a topical gel applied directly to the skin, which can potentially minimize systemic side effects. Researchers are particularly excited about Multiprofen-CC™ due to its targeted delivery method, which allows for concentrated relief at the site of pain without the gastrointestinal or addictive risks associated with oral painkillers. This innovative approach could lead to safer, more effective pain management after surgery.

What evidence suggests that Multiprofen-CC™ might be an effective treatment for postoperative pain?

This trial will compare the effectiveness of Multiprofen-CC™ with a placebo for managing postoperative pain. Research has shown that using a mix of different pain relief methods, like those in Multiprofen-CC™, can effectively manage pain after surgery. Multiprofen-CC™ is a pain-relieving cream applied directly to the skin to ease pain in a specific area. While it is already used for muscle and joint pain, strong evidence for its use in individuals with osteoarthritis undergoing knee replacement surgery is lacking. However, the combination of ingredients in Multiprofen-CC™ suggests it might help reduce pain after surgery and possibly decrease the need for opioids. Early findings indicate it could be a useful addition to standard pain management. ^{1 4 6 7 8}

Who Is on the Research Team?

Giuseppe Valente, MD, MMgt, FRCSC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals with end-stage knee osteoarthritis who are undergoing total knee arthroplasty to replace damaged cartilage. Participants should be experiencing postoperative pain and looking for additional pain management solutions beyond standard treatments.

Inclusion Criteria

I am scheduled for my first knee replacement surgery.

Provide informed consent

Exclusion Criteria

I am unable to give consent by myself.

I have had problems with my kidney or liver function.

I have been using blood thinners for more than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care pain medications and either topical Multiprofen-CC™ or placebo for 6 weeks after surgery

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction with pain management after treatment

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multiprofen-CC™

Trial Overview The study tests whether Multiprofen-CC™, a topical analgesic, when added to the usual post-surgery pain care, can better manage knee pain and reduce opioid use after surgery compared to a placebo (a treatment with no active drug) plus standard care.

How Is the Trial Designed?

Group I: Multiprofen-CC™ Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

KAZM Pharmaceuticals Inc.

Lead Sponsor

Trials

1

Recruited

290+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Intravenous indoprofen (400 mg) was found to be more effective than intramuscular oxicodone (10 mg) in reducing pain from renal colic, with greater pain relief reported at 2-5 minutes after injection and more sustained relief after 3-5 hours.

Indoprofen had significantly fewer side effects compared to oxicodone, particularly in terms of central nervous system effects, suggesting it is a safer alternative for acute pain management in renal colic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a narcotic (oxicone) and a non-narcotic anti-inflammatory analgesic (indoprofen) in the treatment of renal colic. Persson, NH., Bergqvist, D., Melander, A., et al.[2020]

Multimodal analgesic combinations, which include fixed-dose combinations of analgesics like acetaminophen, aspirin, and ibuprofen, can improve pain relief while minimizing adverse effects, making them effective for managing pain of various origins.

There is a need for ongoing research to determine the best combinations and dosages of analgesics tailored to individual patients to achieve optimal pain relief and reduce the risk of adverse drug interactions, especially considering the common use of over-the-counter medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetaminophen, aspirin, or Ibuprofen in combination analgesic products. Barkin, RL.[2020]

In a study involving 240 patients with severe postoperative pain after cesarean section, both 100 mg and 50 mg doses of ketoprofen were found to be significantly more effective than acetaminophen and placebo for pain relief, with the 100 mg dose providing the greatest analgesia.

Ketoprofen not only offered effective and long-lasting pain relief but also had a better safety profile compared to the combination of acetaminophen and oxycodone, as fewer patients experienced adverse effects when taking ketoprofen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoprofen, acetaminophen plus oxycodone, and acetaminophen in the relief of postoperative pain. Sunshine, A., Olson, NZ., Zighelboim, I., et al.[2019]

Postoperative pain is common and can lead to chronic pain if not treated effectively; multimodal analgesia, including NSAIDs and opioids, is recommended to manage this pain safely.

The combination of dexketoprofen and tramadol is highlighted as a particularly effective and safe option for postoperative pain control, helping to minimize opioid use and reduce the risk of persistent pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review. Mayoral Rojals, V., Charaja, M., De Leon Casasola, O., et al.[2022]

In a 4-week study involving elderly patients with moderate to severe pain, 89% experienced significant pain relief within the first week of treatment with suprofen, indicating its rapid efficacy.

Suprofen was well tolerated among participants, with no drug-related withdrawals, suggesting it is a safe option for managing pain in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of suprofen in the treatment of elderly patients with pain of diverse etiology. Denis, FR., de Beer, JM.[2018]

Effective postoperative pain management requires a multimodal approach tailored to the specific type of surgery, which can enhance patient comfort and reduce complications.

Recent advancements in pain management include the rediscovery of existing medications like Gabapentin and new combinations like oral oxycodone with naloxone, highlighting the ongoing evolution of analgesic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New substances and applications for postoperative pain therapy]. Pogatzki-Zahn, EM., Zahn, PK.[2021]

A multicomponent intervention that included a clinical pain pathway and education for nurses significantly improved pain management in postoperative patients, particularly those with opioid tolerance, leading to faster pain relief and higher patient satisfaction.

Post-intervention, the time to achieve adequate pain relief for opioid-tolerant patients decreased from 32.7% requiring over 60 minutes to just 21.3%, and the average PACU discharge time improved by 53 minutes, indicating enhanced recovery quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Improve Postoperative Pain with a Clinical Pathway and Nursing Education Program. Naqib, D., Purvin, M., Prasad, R., et al.[2019]

HTX-011, an extended-release formulation of bupivacaine and meloxicam, offers effective postoperative pain control by releasing its active ingredients over 72 hours, which can enhance patient satisfaction after surgery.

This new formulation provides a longer duration of analgesia compared to traditional local anesthetics, while maintaining a favorable safety profile, making it a promising option in multimodal pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel long-acting local anesthetic - HTX-011 (ZYNRELEF™) for postoperative pain control. Kang, RS., Jin, Z., Gan, TJ.[2022]

Continuous intravenous analgesia with morphine using elastomeric infusors provided effective pain relief for burn patients post-surgery, achieving a visual analog scale (VAS) score of less than 3 within 2 hours of starting treatment.

The method demonstrated a low incidence of side effects compared to traditional morphine delivery methods, with high patient satisfaction, suggesting it is a safe and efficient option for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. García Barreiro, J., Rodriguez, A., Cal, M., et al.[2013]

Using a multimodal analgesia approach, which combines opioids with other medications like ketamine and gabapentinoids, can significantly improve pain management after surgery, reducing both pain at rest and during movement.

This strategy not only lowers the need for opioids, minimizing the risk of side effects, but also helps prevent the development of chronic pain, ultimately enhancing recovery and reducing hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-opioid IV adjuvants in the perioperative period: pharmacological and clinical aspects of ketamine and gabapentinoids. Weinbroum, AA.[2022]

Effective management of post-operative pain can significantly improve patient recovery and reduce the risk of complications, highlighting the importance of thorough preoperative evaluations and individualized treatment plans.

Using a multimodal approach to pain management, which combines various analgesic techniques, can enhance pain relief while minimizing side effects, making it a promising strategy for optimizing post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating post-operative pain]. Blichfeldt-Eckhardt, MR., Jensen, JM., Møller, JF.[2018]

Multimodal analgesia, which combines different types of pain relief methods, effectively manages postoperative pain while reducing the need for opioids and their side effects.

Using adjuncts like acetaminophen, anti-inflammatories, and gabapentinoids, along with techniques like local anesthetic infiltration and nerve blocks, can significantly enhance pain control and improve patient mobility after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia for hip arthroplasty. Tang, R., Evans, H., Chaput, A., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-3-pain-postoperative-2024-e00c5

Multiprofen-CC™ for Postoperative Pain Research shows that using a combination of different pain relief methods, like those in Multiprofen-CC™, can effectively manage postoperative pain. This ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06202989

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty 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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/421521?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Multiprofen-CC™ to Reduce Pain After Total Knee ... 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. Secondary ...

4. studies.bethecure.ca studies.bethecure.ca/find/7e1e419bc2f4ec4340af943700e321a85cc63b63-multiprofen-cc-to-reduce-pain-after-total-knee-

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9718290/

A review of current clinical trials and developments The objective of this paper is to provide a background of OA treatments and its restrictions, upon which the pipeline of pharmacological interventions in OA is ...

6. multiprofencc.ca multiprofencc.ca/about-multiprofen/

About Multiprofen The Multiprofen CC™ Line was created to target specific issues and only uses ingredients necessary for treatment based on clinical data.

7. ctv.veeva.com ctv.veeva.com/study/multiprofen-cc-to-reduce-pain-after-total-knee-arthroplasty

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%).

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560339/

Compounded Topical Pain Creams - NCBI - NIH Safety and Adverse Effects. No data were found on the safety of orphenadrine alone in topical pain creams. From the FDA-approved label, serious adverse ...