Recruiting
Phase 3

Multiprofen-CC

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT06966206

Conditions

Hand Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multiprofen-CC™ plus standard treatment

Placebo plus standard treatment

Study Details

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

Study ID

NCT06966206

Start date

Mar 9, 2026

Status verified date

Apr, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multiprofen-CC™

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

placebo comparator: Placebo

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

Interventions

Multiprofen-CC™ plus standard treatment

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

Placebo plus standard treatment

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

Primary outcome measure

  • Pain intensity [ Time Frame: baseline [week 0] and weeks 2, 4, and 6 ]

Central Contacts and Locations

Central contacts

Breanne Flood, MSc

905-870-1382bflood@stjoes.ca

Kim Irish, BSW

365-336-7598irishkd@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N4A6

Contacts

Breanne Flood, MSc

9058701382floodbl@mcmaster.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • hand osteoarthritis
  • osteoarthritis
  • arthritis
  • topical
  • multiprofen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2026-05-04.