Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2019-04-11

Brief Summary

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Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

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Detailed Description

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The purpose of this randomized, double-blind 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, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

active gel and matching vehicle control gel

Study Groups

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Active Arm

S-Ibuprofen Topical Gel 5%

Group Type EXPERIMENTAL

S-Ibuprofen

Intervention Type DRUG

Topical Gel 5%

Placebo Arm

Vehicle Topical Gel

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle Gel

Interventions

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S-Ibuprofen

Topical Gel 5%

Intervention Type DRUG

Vehicle

Vehicle Gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* history of pain/soreness after exercise
* BMI between 18-30
* negative drug, alcohol, pregnancy screens

Exclusion Criteria

* upper extremity workout in last 3 months
* job or hobby requiring heavy lifting
* history of muscle disorders
* allergy or intolerance to NSAID or study drug
* history of recent pain medication use

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes