Multiprofen-CC to Reduce Pain in Hand Arthritis

NCT06966206 | Recruiting Phase 3

• 1 other identifier: MRP-HAND
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Osteoarthritis

Keywords

hand osteoarthritis; osteoarthritis; arthritis; topical; multiprofen

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  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.

  baseline [week 0] and weeks 2, 4, and 6

Secondary Outcomes (3)

• Hand function

  weeks 2, 4 and 6

• Patients reported improvement

  weeks 2, 4 and 6

• Safety - adverse events

  through study completion, an average of 6 weeks

Study Arms (2)

Multiprofen-CC™

EXPERIMENTAL

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

Drug: Multiprofen-CC™ plus standard treatment

Placebo

PLACEBO COMPARATOR

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

Other: Placebo plus standard treatment

Interventions

Multiprofen-CC™ plus standard treatment DRUG

Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 2 weeks

Multiprofen-CC™

Placebo plus standard treatment OTHER

Standard care pain medications and visually identical topical placebo (1g TID) for 2 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Carolyn Levis, MD, MSc, FRCS(C)

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breanne Flood, MSc

CONTACT

905-870-1382; bflood@stjoes.ca

Kim Irish, BSW

CONTACT

365-336-7598; irishkd@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2x2 crossover randomized placebo-controlled trial

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 11, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)