Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).

Official Title
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A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)

Conditions
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Delayed Onset Muscle Soreness

Intervention / Treatment
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* Drug: Loxoprofen Pain Patch
* Drug: Placebo Patch
* Drug: No Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 18 to 40 years of age are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least moderate on the categorical scale Exclusion Criteria: has engaged in upper extremity exercise for a minimum of 6 months prior to study participation has been working heavy manual or physical labor jobs within 3 months prior to study participation. has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs has skin lesions such as psoriasis at the application site has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc. has an allergy-related skin condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Loxoprofen Pain Patch<br>One Active Pain Patch containing loxoprofen applied once daily for 3 days | Drug: Loxoprofen Pain Patch<br>* One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days<br>|
| Placebo Comparator: Placebo Patch<br>One Placebo Patch applied once daily for 3 days | Drug: Placebo Patch<br>* One Placebo Patch applied daily for 3 days<br>|
| Other: No Treatment<br>No Treatment for 3 days | Drug: No Treatment<br>* No Treatment for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement |  | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest |  | 0-24 hours | 
| Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement |  | 0-48 hours | 
| Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest |  | 0-48 hours | 
| Time to onset of first perceptible pain relief |  | First 4 hours after Dose 1 | 
| Time to onset of meaningful pain relief |  | First 4 hours after Dose 1 | 
| Subjects global impression of medication |  | Day 10 |