Trial | NCT02324985  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dexibuprofen ...

  • Study Participants

    147
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 Started
Jan 31
2015
Primary Completion
Jul 31
2015
Study Completion
Jun 30
2016
Last Update
Feb 25
2019

Drug S-Ibuprofen Topical Gel 5%

S-Ibuprofen Topical Gel 5% applied every 6 hours

  • Other names: Active Gel

Drug Vehicle Topical Gel

Vehicle Topical Gel applied every 6 hours

  • Other names: Vehicle Gel

Active Arm Active Comparator

S-Ibuprofen Topical Gel 5%

Placebo Arm Placebo Comparator

Vehicle Topical Gel

Criteria 

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
No Results Posted