Pilot Study Comparing the Efficacy and Safety of a New Pa... | NCT02602353

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

NCT02602353

Sponsor

Lead Chemical Co., Ltd.

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

42Actual

Phase

Phase 2

Conditions

Delayed Onset Muscle Soreness

Interventions

Loxoprofen Pain Patch
Placebo Patch
No Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 9, 2015

First Submission Date that Met QC Criteria

Nov 9, 2015

First Posted Date

Nov 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 25, 2016

Certification/Extension First Submitted that Passed QC Review

Oct 26, 2016

Certification/Extension First Posted Date

Oct 28, 2016Estimated

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Name	Class
Cardinal Health	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Loxoprofen Pain Patch	Experimental	One Active Pain Patch containing loxoprofen applied once daily for 3 days	Drug: Loxoprofen Pain Patch
Placebo Patch	Placebo Comparator	One Placebo Patch applied once daily for 3 days	Drug: Placebo Patch
No Treatment	Other	No Treatment for 3 days	Drug: No Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Loxoprofen Pain Patch	Drug	One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days	Loxoprofen Pain Patch

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Derek Muse, MD	Jean Brown Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jean Brown Research		Salt Lake City	Utah	84124	United States