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Topical Analgesic

Topical analgesia (+Menthol) for Osteoarthritis

Phase 2 & 3
Waitlist Available
Led By Nick Smith, MD (FRCSC)
Research Sponsored by Memorial University of Newfoundland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women aged 50-80 years
Body mass index (BMI) less than 40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

Knee osteoarthritis (OA) is a progressive disease that can be accompanied by considerable joint pain and dysfunction. It is a goal in the medical field to find effective treatments for knee OA that are non-interventional, have minor or no negative side effects, and are relatively easy to administer for the patient and health care professionals. Biofreeze, a topical analgesic containing menthol, is an easily accessible gel, with no known serious negative side effects. If the application of Biofreeze can reduce the pain and dysfunction associated with knee OA, it could be an effective treatment for patients. The objective of the study is to assess how 4 weeks of Biofreeze application to a knee affected by OA effects pain and dysfunction associated with the disease.

Eligible Conditions
  • Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy comparison of (Biofreeze) Menthol 4%, Menthol 0% as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), version 3.0

Side effects data

From 2017 Phase 3 trial • 229 Patients • NCT03095508
2%
Throat irritation
1%
Cough
1%
Oral discomfort
1%
Nausea
1%
Chest pain
1%
Gingival pain
1%
Leukocytosis
1%
Abdominal pain upper
1%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Angal S (Arm A)
ANTI-ANGIN® FORMULA (Arm B)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical analgesia (+Menthol)Experimental Treatment1 Intervention
Biofreeze Topical Gel with active ingredient (Menthol 4%)
Group II: Topical analgesia (-Menthol)Placebo Group1 Intervention
Biofreeze Topical Gel with no active ingredient (Menthol 0%)

Find a Location

Who is running the clinical trial?

Memorial University of NewfoundlandLead Sponsor
68 Previous Clinical Trials
1,831,922 Total Patients Enrolled
2 Trials studying Osteoarthritis
268 Patients Enrolled for Osteoarthritis
Nick Smith, MD (FRCSC)Principal InvestigatorMemorial University Orthopaedic Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Biofreeze and the Effect on Knee Osteoarthritis
Nick Smith 2020. "Biofreeze and the Effect on Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04351594.
All > Knee Osteoarthritis
~23 spots leftby Apr 2025
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