Multiprofen-CC for Hand Arthritis

(MRP-HAND Trial)

Overseen By Breanne Flood, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: McMaster University

Must not be taking: Daily opioids

Disqualifiers: Pregnancy, Kidney impairment, Rheumatoid, 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: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called Multiprofen-CC to determine its effectiveness in reducing pain and improving hand function for individuals with hand osteoarthritis. Participants will use both the Multiprofen-CC cream and a placebo (a cream without active medicine) to compare effects. The trial will monitor changes in pain, hand function, opioid use, and overall feelings of improvement, while also checking for side effects. It suits adults diagnosed with hand osteoarthritis who experience pain or loss of function affecting daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you use daily opioids for chronic pain other than hand arthritis, you may not be eligible to participate.

Is there any evidence suggesting that Multiprofen-CC is likely to be safe for humans?

Research shows that Multiprofen-CC is being tested for its ability to relieve pain from hand arthritis. This cream contains several ingredients—ketoprofen, baclofen, amitriptyline, and lidocaine—commonly used to manage pain and swelling.

Earlier studies found that most people tolerated Multiprofen-CC well. Some might experience mild skin irritation at the application site, a common reaction with topical creams.

However, rare reports of more serious side effects have occurred with similar creams. For instance, one case involved an accidental overdose with a cream containing these ingredients.

Being in a Phase 3 trial indicates that earlier tests did not reveal major safety issues, suggesting the treatment has been tried on some people and found safe enough for further study.

Consult a healthcare professional about any concerns before joining a trial. They can provide advice tailored to individual health needs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hand arthritis?

Unlike the standard treatments for hand arthritis, which often involve oral NSAIDs or corticosteroid injections, Multiprofen-CC™ is a topical cream that combines four active ingredients: ketoprofen, baclofen, amitriptyline, and lidocaine. This unique formulation not only targets inflammation but also addresses pain through multiple mechanisms, including muscle relaxation and nerve pain relief. Researchers are excited about its potential to offer faster and more comprehensive pain relief with fewer systemic side effects, thanks to its topical application.

What evidence suggests that Multiprofen-CC might be an effective treatment for hand osteoarthritis?

In earlier studies, Multiprofen-CC has shown promise in reducing pain for joint conditions. Research shows that this cream, containing ketoprofen, baclofen, amitriptyline, and lidocaine, can effectively lower pain levels when applied to the skin. For example, a study with patients who had knee osteoarthritis found that using Multiprofen-CC reduced their pain and decreased their need for opioid painkillers. The mix of active ingredients is believed to block pain signals and provide relief. In this trial, participants will receive either Multiprofen-CC or a placebo cream to assess its effectiveness in improving pain and movement in arthritis patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Carolyn Levis, MD, MSc, FRCS(C)

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

Adults with hand osteoarthritis can join this trial. They'll use a cream called Multiprofen-CC or a placebo, alongside their standard treatment. Participants must be able to apply the cream three times daily and attend three study visits.

Inclusion Criteria

Provide informed consent

I experience hand pain or difficulty using my hands that affects my daily activities.

I have been diagnosed with hand osteoarthritis.

Exclusion Criteria

I am unable to give consent by myself.

Pregnant or breastfeeding

I have been diagnosed with rheumatoid arthritis or another inflammatory joint condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants apply 1 gram of Multiprofen-CC or placebo cream to their hands three times a day for 2 weeks, in a random order

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multiprofen-CC

Trial Overview The trial tests if Multiprofen-CC cream reduces hand arthritis pain over 4 weeks compared to a placebo. It also examines its effects on hand function, opioid usage, and overall patient satisfaction with improvement.

How Is the Trial Designed?

Group I: Multiprofen-CC™ Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

The placebo is the base cream with no medicinal ingredients Dose: 1.0g, 3 times per day for 2 weeks

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

The Research Institute of St Joe's Hamilton

Collaborator

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06966206

Multiprofen-CC to Reduce Pain in Hand Arthritis It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. trial.medpath.com trial.medpath.com/clinical-trial/0abb60a5dac72ba7/multiprofen-cc-hand-arthritis-pain

Multiprofen-CC to Reduce Pain in Hand Arthritis | MedPath This clinical trial aims to find out if using 1 gram of Multiprofen-CC cream on the hands three times a day for 4 weeks can help reduce pain in adults with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06202989

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

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

Multiprofen-CC™ for Postoperative Pain This trial tests whether a topical pain cream, Multiprofen-CC™, can reduce knee pain and the need for opioids after knee replacement surgery.

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

Compounded Topical Pain Creams - NCBI - NIH Pain was reduced to 3 by a test application of compounded topical baclofen 5 percent cream, which was said to be a greater reduction than with compounded ...