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)

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).

Study Overview

• Status: Completed
• Conditions: Delayed Onset Muscle Soreness
• Intervention / Treatment: Drug: Loxoprofen Pain Patch; Drug: Placebo Patch; Drug: No Treatment

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loxoprofen Pain Patch; One Active Pain Patch containing loxoprofen applied once daily for 3 days	Drug: Loxoprofen Pain Patch; One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo Comparator: Placebo Patch; One Placebo Patch applied once daily for 3 days	Drug: Placebo Patch; One Placebo Patch applied daily for 3 days
Other: No Treatment; No Treatment for 3 days	Drug: No Treatment; No Treatment for 3 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lead Chemical Co., Ltd.
• Collaborators: Cardinal Health

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: LEAD-PhII-050