Phase II Study of AP0302 5% Versus a Vehicle Comparator

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Delayed Onset Muscle Soreness
• Intervention / Treatment: Drug: S-Ibuprofen Topical Gel 5%; Drug: Vehicle Topical Gel

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).

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Arm; S-Ibuprofen Topical Gel 5%	Drug: S-Ibuprofen Topical Gel 5%; S-Ibuprofen Topical Gel 5% applied every 6 hours; Other Names: Active Gel
Placebo Comparator: Placebo Arm; Vehicle Topical Gel	Drug: Vehicle Topical Gel; Vehicle Topical Gel applied every 6 hours; Other Names: Vehicle Gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	SPID 48rest	0-48 hours

Collaborators and Investigators

• Sponsor: Aponia Laboratories, Inc.
• Investigators: Principal Investigator: Sonia Singla, DO, Lotus Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: muscle soreness
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: AP-005