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

Primary Purpose

Delayed Onset Muscle Soreness

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Loxoprofen Pain Patch

Placebo Patch

No Treatment

About this trial

This is an interventional treatment trial for Delayed Onset Muscle Soreness

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Loxoprofen Pain Patch

Placebo Patch

No Treatment

Arm Description

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

One Placebo Patch applied once daily for 3 days

No Treatment for 3 days

Outcomes

Primary Outcome Measures

Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement

Secondary Outcome Measures

Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest

Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement

Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest

Time to onset of first perceptible pain relief

Time to onset of meaningful pain relief

Subjects global impression of medication

Full Information

NCT ID

NCT02602353

First Posted

November 9, 2015

Last Updated

October 26, 2016

Sponsor

Lead Chemical Co., Ltd.

Collaborators

Cardinal Health

1. Study Identification

Unique Protocol Identification Number

NCT02602353

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lead Chemical Co., Ltd.

Collaborators

Cardinal Health

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delayed Onset Muscle Soreness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loxoprofen Pain Patch

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Patch

Arm Type

Placebo Comparator

Arm Description

One Placebo Patch applied once daily for 3 days

Arm Title

No Treatment

Arm Type

Other

Arm Description

No Treatment for 3 days

Intervention Type

Drug

Intervention Name(s)

Loxoprofen Pain Patch

Intervention Description

One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days

Intervention Type

Drug

Intervention Name(s)

Placebo Patch

Intervention Description

One Placebo Patch applied daily for 3 days

Intervention Type

Drug

Intervention Name(s)

No Treatment

Intervention Description

No Treatment for 3 days

Primary Outcome Measure Information:

Title

Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement

Time Frame

0-24 hours

Secondary Outcome Measure Information:

Title

Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest

Time Frame

0-24 hours

Title

Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement

Time Frame

0-48 hours

Title

Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest

Time Frame

0-48 hours

Title

Time to onset of first perceptible pain relief

Time Frame

First 4 hours after Dose 1

Title

Time to onset of meaningful pain relief

Time Frame

First 4 hours after Dose 1

Title

Subjects global impression of medication

Time Frame

Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Derek Muse, MD

Organizational Affiliation

Jean Brown Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jean Brown Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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