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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02602353

Enrollment

Registered

2015-11-11

Start date

2015-10-31

Completion date

2015-12-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Onset Muscle Soreness

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).

Interventions

DRUGLoxoprofen Pain Patch

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

DRUGPlacebo Patch

One Placebo Patch applied daily for 3 days

DRUGNo Treatment

No Treatment for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement	0-24 hours

Secondary

Measure	Time frame
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
Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest	0-24 hours
Time to onset of meaningful pain relief	First 4 hours after Dose 1
Subjects global impression of medication	Day 10
Time to onset of first perceptible pain relief	First 4 hours after Dose 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026