Phase II Study of AP0302 5% Versus a Vehicle Comparator

Aponia Laboratories

Status and phase: Completed; Phase 2

Conditions: Delayed Onset Muscle Soreness; Pain

Treatments: Drug: S-Ibuprofen Topical Gel 5%; Drug: Vehicle Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02324985

AP-005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 147 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 2 patient groups, including a placebo group

Active Arm

Active Comparator group

Description:

S-Ibuprofen Topical Gel 5%

Treatment:

Drug: S-Ibuprofen Topical Gel 5%

Placebo Arm

Placebo Comparator group

Description:

Vehicle Topical Gel

Treatment:

Drug: Vehicle Topical Gel