Multiprofen-CC to Reduce Pain in Hand Arthritis

NCT ID: NCT06966206

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-08-01

Brief Summary

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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

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Conditions

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Hand Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

2x2 crossover randomized placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multiprofen-CC™

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

Group Type EXPERIMENTAL

Multiprofen-CC™ plus standard treatment

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo plus standard treatment

Intervention Type OTHER

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

Interventions

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Multiprofen-CC™ plus standard treatment

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

Intervention Type DRUG

Placebo plus standard treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Institute of St Joe's Hamilton

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn Levis, MD, MSc, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Kim Madden, PhD

Role: CONTACT

289-237-7380

Breanne Flood, MSc

Role: CONTACT

905-870-1382

Facility Contacts

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Breanne Flood, MSc

Role: primary

9058701382

Other Identifiers

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MRP-HAND

Identifier Type: -

Identifier Source: org_study_id

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