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

Phase 2

Completed

• Conditions: Delayed Onset Muscle Soreness
• Interventions: Drug: Loxoprofen Pain Patch; Drug: Placebo Patch; Drug: No Treatment

• Registration Number: NCT02602353
• Lead Sponsor: Lead Chemical Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Disposition First Submitted: 2016-10-25
• Disposition First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Disposition First Posted: 2016-10-28
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loxoprofen Pain Patch	Loxoprofen Pain Patch	One Active Pain Patch containing loxoprofen applied once daily for 3 days
Placebo Patch	Placebo Patch	One Placebo Patch applied once daily for 3 days
No Treatment	No Treatment	No Treatment for 3 days

Primary Outcome Measures

Name	Time	Method
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement	0-24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States