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

Completed · Phase 2 · Has a placebo group

Conditions studied: Delayed Onset Muscle Soreness

In brief

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).

Key facts

Study ID

NCT02602353

Run by

Lead Chemical Co., Ltd.

People needed

42

Starts

2015-10-01

Expected to finish

2015-12-01

Last updated by the study team

2016-10-28

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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