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
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Loxoprofen's analgesic effects on DOMS compared to placebo?
How does the Loxoprofen Pain Patch compare to standard NSAID treatments for DOMS in clinical efficacy?
Which biomarkers correlate with response to Loxoprofen transdermal delivery in musculoskeletal pain?
What adverse events were reported in NCT02602353 and how do they compare to other NSAID patches?
Are there combination therapies involving Loxoprofen for DOMS that show enhanced analgesic outcomes?
Trial Locations
- Locations (1)
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Jean Brown Research🇺🇸Salt Lake City, Utah, United States