Trial | NCT02602353  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    loxoprofen ...

  • Study Participants

    42
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).
Study Started
Oct 31
2015
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Oct 28
2016
Estimate

Drug Loxoprofen Pain Patch

One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days

Drug Placebo Patch

One Placebo Patch applied daily for 3 days

Drug No Treatment

No Treatment for 3 days

Loxoprofen Pain Patch Experimental

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

Placebo Patch Placebo Comparator

One Placebo Patch applied once daily for 3 days

No Treatment Other

No Treatment for 3 days

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
No Results Posted