Hand OsteoarthritisPhase 3MRP-HANDNCT06966206
Multiprofen-CC to Reduce Pain in Hand Arthritis
A Phase 3 study testing Multiprofen-CC™ plus standard treatment in people with Hand Osteoarthritis, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Multiprofen-CC™ plus standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2026to 1 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
Breanne Flood, MSc, 9058701382, floodbl@mcmaster.ca
About this study
Official title: Multiprofen-CC to Reduce Pain in Hand Arthritis (MRP-HAND): A Crossover Randomized Controlled Trial
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
- Being tested
- Multiprofen-CC™ plus standard treatment, Placebo plus standard treatment
- Keywords
- hand osteoarthritis, osteoarthritis, arthritis, topical, multiprofen
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofen-CC™ plus standard treatmentDrug
Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 2 weeks
Placebo plus standard treatmentOther
Standard care pain medications and visually identical topical placebo (1g TID) for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Multiprofen-CC™ | Experimental | Multiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 2 weeks Receives: 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 Receives: Other: Placebo plus standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline [week 0] and weeks 2, 4, and 6
Secondary outcomes (3)
Hand function
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.
Measured: weeks 2, 4 and 6
Patients reported improvement
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.
Measured: weeks 2, 4 and 6
Safety - adverse events
Hand-related and medication-related serious and non-serious adverse events
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start9 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2x2 crossover randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Levis, St. Joseph's Healthcare Hamilton
- Investigators
- Carolyn Levis, MD, MSc, FRCS(C), Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966206
- Sponsor's protocol ID
- MRP-HAND
- Acronym
- MRP-HAND
- Status last verified
- Apr 2026
- First submitted
- 1 May 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiprofen-CC to Reduce Pain in Hand Arthritis (MRP-HAND): A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06966206
- Acronym / sponsor ID
- MRP-HAND / MRP-HAND
- Conditions
- Hand Osteoarthritis
- Keywords
- hand osteoarthritis, osteoarthritis, arthritis, topical, multiprofen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2x2 crossover randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multiprofen-CC™ | Experimental | Drug: Multiprofen-CC™ plus standard treatmentMultiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 2 weeks |
| Placebo | Placebo comparator | Other: Placebo plus standard treatmentThe placebo is the base cream with no medicinal ingredients Dose: 1.0g, 3 times per day for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiprofen-CC™ plus standard treatmentStandard care pain medications and topical Multiprofen-CC™ (1g TID) for 2 weeks | Drug | Multiprofen-CC™ |
| Placebo plus standard treatmentStandard care pain medications and visually identical topical placebo (1g TID) for 2 weeks | Other | Placebo |
Primary outcome
Pain intensity
Time frame: 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.
3 secondary outcomes
Hand function
Time frame: weeks 2, 4 and 6
Patients reported improvement
Time frame: weeks 2, 4 and 6
Safety - adverse events
Time frame: through study completion, an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolyn Levis, MD, MSc, FRCS(C) principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multiprofen-CC™ plus standard treatment in people with Hand Osteoarthritis, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Breanne Flood, MSc (905-870-1382, bflood@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: baseline [week 0] and weeks 2, 4, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.