Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | December 2015 |
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)
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).
patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle
Soreness (DOMS).
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
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