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

Delayed Onset Muscle Soreness Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602353
• Other study ID #: LEAD-PhII-050
• 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

• Delayed Onset Muscle Soreness
• Myalgia

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