Phase II Study of AP0302 5% Versus a Vehicle Comparator

Aponia Laboratories, Inc.147 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

147

Conditions

Pain Delayed Onset Muscle Soreness

Interventions

S-Ibuprofen Topical Gel 5%DRUG

S-Ibuprofen Topical Gel 5% applied every 6 hours

Vehicle Topical GelDRUG

Vehicle Topical Gel applied every 6 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lotus Clinical Research, LLC

Pasadena, California, United States

Outcomes

Primary Outcomes

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

SPID 24

Time frame: 0-24 hours

Secondary Outcomes

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

SPID 48movement

Time frame: 0-48 hours

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

SPID 48rest

Time frame: 0-48 hours

Data from ClinicalTrials.gov

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