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)

Lead Chemical Co., Ltd.1 site in 1 country42 target enrollmentOctober 2015

ConditionsDelayed Onset Muscle Soreness

InterventionsLoxoprofen Pain Patch Placebo Patch No Treatment

DrugsLoxoprofen Pain Patch Placebo Patch No Treatment

Overview

Phase: Phase 2
Intervention: Loxoprofen Pain Patch
Conditions: Delayed Onset Muscle Soreness
Sponsor: Lead Chemical Co., Ltd.
Enrollment: 42
Locations: 1
Primary Endpoint: Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lead Chemical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Loxoprofen Pain Patch

One Active Pain Patch containing loxoprofen applied once daily for 3 days

Intervention: Loxoprofen Pain Patch

Placebo Patch

One Placebo Patch applied once daily for 3 days

Intervention: Placebo Patch

No Treatment

No Treatment for 3 days

Intervention: No Treatment

Outcomes

Primary Outcomes

Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement

Time Frame: 0-24 hours

Secondary Outcomes

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)