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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lead Chemical Co., Ltd.; Lead Chemical Co.,Ltd.
• Collaborator: Cardinal Health
• Treatments: Loxoprofen

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