Back to results

Phase II Study of AP0302 5% Versus a Vehicle Comparator

Primary Purpose

Pain, Delayed Onset Muscle Soreness

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

S-Ibuprofen Topical Gel 5%

Vehicle Topical Gel

About this trial

This is an interventional treatment trial for Pain focused on measuring muscle soreness

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Lotus Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Arm

Placebo Arm

Arm Description

S-Ibuprofen Topical Gel 5%

Vehicle Topical Gel

Outcomes

Primary Outcome Measures

Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

SPID 24

Secondary Outcome Measures

Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement

SPID 48movement

Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest

SPID 48rest

Full Information

NCT ID

NCT02324985

First Posted

December 19, 2014

Last Updated

February 21, 2019

Sponsor

Aponia Laboratories, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02324985

Brief Title

Phase II Study of AP0302 5% Versus a Vehicle Comparator

Official Title

Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aponia Laboratories, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

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

Pain, Delayed Onset Muscle Soreness

Keywords

muscle soreness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Arm

Arm Type

Active Comparator

Arm Description

S-Ibuprofen Topical Gel 5%

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Vehicle Topical Gel

Intervention Type

Drug

Intervention Name(s)

S-Ibuprofen Topical Gel 5%

Other Intervention Name(s)

Active Gel

Intervention Description

S-Ibuprofen Topical Gel 5% applied every 6 hours

Intervention Type

Drug

Intervention Name(s)

Vehicle Topical Gel

Other Intervention Name(s)

Vehicle Gel

Intervention Description

Vehicle Topical Gel applied every 6 hours

Primary Outcome Measure Information:

Title

Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

Description

SPID 24

Time Frame

0-24 hours

Secondary Outcome Measure Information:

Title

Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement

Description

SPID 48movement

Time Frame

0-48 hours

Title

Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest

Description

SPID 48rest

Time Frame

0-48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonia Singla, DO

Organizational Affiliation

Lotus Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lotus Clinical Research, LLC

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of AP0302 5% Versus a Vehicle Comparator

We'll reach out to this number within 24 hrs