Phase II Study of AP0302 5% Versus a Vehicle Comparator | NCT02324985

Studies
Phase II Study of AP0302 5% Versus a Vehicle Comparator

NCT02324985

Sponsor

Aponia Laboratories, Inc.

Status

Completed

Last Update Posted

Feb 25, 2019Actual

Enrollment

147Actual

Phase

Phase 2

Conditions

Pain
Delayed Onset Muscle Soreness

Interventions

S-Ibuprofen Topical Gel 5%
Vehicle Topical Gel

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

Jan 2019

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

Jan 2015Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Dec 19, 2014

First Submission Date that Met QC Criteria

Dec 19, 2014

First Posted Date

Dec 24, 2014Estimated

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

Jan 27, 2019

Certification/Extension First Submitted that Passed QC Review

Feb 21, 2019

Certification/Extension First Posted Date

Feb 25, 2019Actual

Last Update Submitted Date

Feb 21, 2019

Last Update Posted Date

Feb 25, 2019Actual

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

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

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

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Arm	Active Comparator	S-Ibuprofen Topical Gel 5%	Drug: S-Ibuprofen Topical Gel 5%
Placebo Arm	Placebo Comparator	Vehicle Topical Gel	Drug: Vehicle Topical Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-Ibuprofen Topical Gel 5%	Drug	S-Ibuprofen Topical Gel 5% applied every 6 hours	Active Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement	SPID 24	0-24 hours

Secondary Outcomes

Measure	Description	Time Frame
Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement	SPID 48movement	0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no clinically significant medical conditions
BMI between 18-30
negative drug, alcohol, pregnancy screens
other protocol-defined inclusion criteria may apply

Exclusion Criteria:

no upper extremity workout in last 6 months
no job requiring heavy lifting
history of muscle disorders
allergy or intolerance to study drug
history of recent pain medication use
other protocol-defined exclusion criteria may apply

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonia Singla, DO	Lotus Clinical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lotus Clinical Research, LLC		Pasadena	California	91105	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D063806	Myalgia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009135	Muscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided