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Nonsteroidal Anti-inflammatory Drug (NSAID)

HKT-500 Ketoprofen Topical Patch for Ankle Sprain

Phase 3
Waitlist Available
Research Sponsored by Hisamitsu Pharmaceutical Co., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Grade I or Grade II Ankle Sprain.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

Summary

The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Eligible Conditions
  • Ankle Sprain

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HKT-500 Ketoprofen Topical PatchExperimental Treatment1 Intervention
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.
Group II: Placebo PatchPlacebo Group1 Intervention
Treatment with placebo patch
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketoprofen
FDA approved

Find a Location

Who is running the clinical trial?

Hisamitsu Pharmaceutical Co., Inc.Lead Sponsor
6 Previous Clinical Trials
1,722 Total Patients Enrolled
Kenichi FurutaStudy DirectorHisamitsu Pharmaceutical Co., Inc.
2 Previous Clinical Trials
668 Total Patients Enrolled
~15 spots leftby Dec 2025
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