Multiprofen-CC to Reduce Pain in Hand Arthritis (MRP-HAND)

McMaster University

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Hand Osteoarthritis

Treatments: Other: Placebo plus standard treatment; Drug: Multiprofen-CC™ plus standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06966206

MRP-HAND

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (18+)
• Have been diagnosed with hand osteoarthritis according to American College of Rheumatology criteria
• Experience pain and/or loss of function in one or both hands that interferes with daily life
• Provide informed consent

Exclusion criteria

• Unable to consent
• Unable or unwilling to follow study protocol
• Known allergy or contraindication to any of the study drugs or their ingredients
• Have open wounds/cuts and/or skin conditions on the hand area
• Pregnant or breastfeeding
• History of impaired kidney or liver function
• Rheumatoid or other inflammatory arthropathy
• Hand surgery within the past 6 months or planned within the study period.
• Use daily opioids (other than short acting codeine) for a chronic pain condition other than hand arthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Multiprofen-CC™

Experimental group

Description:

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

Treatment:

Drug: Multiprofen-CC™ plus standard treatment

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo plus standard treatment