A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity

Study Overview
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Brief Summary
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The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.

Official Title
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A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: K-285
* Drug: Menthol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must provide informed consent before any study-specific evaluation is performed. Subject is male and female aged 18 to 35 years, inclusive. Subject has a body mass index of 18 to 32 kg/m2, inclusive. Subject meets all inclusion criteria outlined in the Clinical Study Protocol. Exclusion Criteria: Subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities. Subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments. Subject has received oral or topical analgesic medications within 14 days before the Screening Visit. Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm A<br>K-285 | Drug: K-285<br>* 88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.<br>|
| Active Comparator: Treatment Arm B<br>Menthol | Drug: Menthol<br>* 88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing | Using a 0-100 point electronic visual analog scale (eVAS) | 0 to 24 hours after the first gel application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID 0-24 for study leg at rest | Using a 0-100 point eVAS scale | 0 to 24 hours after the first gel application | 
| SPID 0-12 for study leg while standing and at rest | Using a 0-100 point eVAS scale. | 0 to 12 hours after the first gel application | 
| SPID 0-48 for study leg while standing and at rest | Using a 0-100 point eVAS scale | 0 to 48 hours after the first gel application | 
| SPID 0-72 for study leg while standing and at rest | Using a 0-100 point eVAS scale | 0 to 72 hours after the first gel application |