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

Lead Chemical

Status and phase: Completed; Phase 2

Conditions: Delayed Onset Muscle Soreness

Treatments: Drug: Placebo Patch; Drug: No Treatment; Drug: Loxoprofen Pain Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT02602353

LEAD-PhII-050

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups, including a placebo group

Loxoprofen Pain Patch

Experimental group

Description:

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

Treatment:

Drug: Loxoprofen Pain Patch

Placebo Patch

Placebo Comparator group

Description:

One Placebo Patch applied once daily for 3 days

Treatment:

Drug: Placebo Patch

No Treatment

Other group

Description:

No Treatment for 3 days

Treatment:

Drug: No Treatment