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

Sponsor

Lead Chemical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02602353

Collaborator

Cardinal Health (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Delayed Onset Muscle Soreness	Drug: Loxoprofen Pain Patch Drug: Placebo Patch Drug: No Treatment	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement [0-24 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Brown Research	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Lead Chemical Co., Ltd.
Cardinal Health

Investigators

Principal Investigator: Derek Muse, MD, Jean Brown Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lead Chemical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02602353

Other Study ID Numbers:

LEAD-PhII-050

First Posted:

Nov 11, 2015

Last Update Posted:

Oct 28, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Myalgia

Loxoprofen

Study Results

No Results Posted as of Oct 28, 2016