Phase II Study of AP0302 5% Versus a Vehicle Comparator

NCT ID: NCT02324985

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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).

Conditions

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Pain Delayed Onset Muscle Soreness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active Arm

S-Ibuprofen Topical Gel 5%

Group Type ACTIVE_COMPARATOR

S-Ibuprofen Topical Gel 5%

Intervention Type DRUG

S-Ibuprofen Topical Gel 5% applied every 6 hours

Placebo Arm

Vehicle Topical Gel

Group Type PLACEBO_COMPARATOR

Vehicle Topical Gel

Intervention Type DRUG

Vehicle Topical Gel applied every 6 hours

Interventions

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S-Ibuprofen Topical Gel 5%

S-Ibuprofen Topical Gel 5% applied every 6 hours

Intervention Type DRUG

Vehicle Topical Gel

Vehicle Topical Gel applied every 6 hours

Intervention Type DRUG

Other Intervention Names

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Active Gel Vehicle Gel

Eligibility Criteria

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Inclusion Criteria

* no clinically significant medical conditions
* BMI between 18-30
* negative drug, alcohol, pregnancy screens

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aponia Laboratories, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonia Singla, DO

Role: PRINCIPAL_INVESTIGATOR

Lotus Clinical Research

Locations

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Lotus Clinical Research, LLC

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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AP-005

Identifier Type: -

Identifier Source: org_study_id

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