Phase II Study of AP0302 5% Versus a Vehicle Comparator

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324985
• Other study ID #: AP-005
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: Aponia Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Onset Muscle Soreness
• Myalgia
• Pain

Intervention

Drug:
• S-Ibuprofen Topical Gel 5%
S-Ibuprofen Topical Gel 5% applied every 6 hours
• Vehicle Topical Gel
Vehicle Topical Gel applied every 6 hours

Locations

Country	Name	City	State
United States	Lotus Clinical Research, LLC	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Aponia Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement	SPID 24	0-24 hours
Secondary	Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement	SPID 48movement	0-48 hours
Secondary	Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest	SPID 48rest	0-48 hours