Multiprofen-CC to Reduce Pain in Hand Arthritis

Phase 3

Not yet recruiting

• Conditions: Hand Osteoarthritis
• Interventions: Drug: Multiprofen-CC™ plus standard treatment; Other: Placebo plus standard treatment

• Registration Number: NCT06966206
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multiprofen-CC™	Multiprofen-CC™ plus standard treatment	Multiprofen-CC™ \[ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)\] Dose: 1.0g, 3 times per day for 2 weeks
Placebo	Placebo plus standard treatment	The placebo is the base cream with no medicinal ingredients Dose: 1.0g, 3 times per day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Pain intensity	baseline [week 0] and weeks 2, 4, and 6	Average pain intensity will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Scores are collected before and after each treatment period. Higher scores indicate greater pain intensity and thus a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Pain interference	weeks 2, 4 and 6	Measured using the 7 pain interference items from the Brief Pain Inventory - Short Form (BPI-SF). Each item is rated on a scale from 0 to 10, where 0 indicates "does not interfere" and 10 indicates "completely interferes." The total pain interference score is calculated as the average of the seven items, with a minimum possible value of 0 and a maximum of 10. Higher scores indicate worse pain interference and thus a worse outcome.
Hand function	weeks 2, 4 and 6	Measured using the Michigan Hand Outcomes Questionnaire (MHQ), a validated instrument assessing hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. The total score ranges from 0 to 100, with higher scores representing better overall hand function and patient-reported outcomes.
Patients reported improvement	weeks 2, 4 and 6	Measured using the Patient Global Impression of Change (PGIC) scale, a single-item, patient-reported measure of overall improvement. The scale ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse." Lower scores represent better outcomes.
Safety - adverse events	through study completion, an average of 6 weeks	Hand-related and medication-related serious and non-serious adverse events

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada