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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02602353
Other study ID # LEAD-PhII-050
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2015
Last updated October 26, 2016
Start date October 2015
Est. completion date December 2015

Study information

Verified date October 2016
Source Lead Chemical Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Loxoprofen Pain Patch
One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo Patch
One Placebo Patch applied daily for 3 days
No Treatment
No Treatment for 3 days

Locations

Country Name City State
United States Jean Brown Research Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Lead Chemical Co.,Ltd. Cardinal Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement 0-24 hours No
Secondary Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest 0-24 hours No
Secondary Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement 0-48 hours No
Secondary Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest 0-48 hours No
Secondary Time to onset of first perceptible pain relief First 4 hours after Dose 1 No
Secondary Time to onset of meaningful pain relief First 4 hours after Dose 1 No
Secondary Subjects global impression of medication Day 10 No
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