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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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 hand osteoarthritis, compared to a placebo (a cream with no active medicine). The research team will also look at how Multiprofen-CC affects hand function, opioid use, and how patients feel about their overall improvement. In addition, the research team will keep track of any side effects. Participants will: * Use both Multiprofen-CC and a placebo (a cream with no active medicine) during the study, in a random order. * Be asked to apply 1 gram of cream to their hands three times a day for 2 weeks, following the manufacturer's instructions. * Attend a visit before starting the study, after 2 weeks, and after 6 weeks. * Report any symptoms they experience during the study.

Research Team

Carolyn Levis, MD, MSc, FRCS(C)

Principal Investigator

McMaster University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+