Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

Aponia Laboratories

Status and phase: Completed; Phase 2

Conditions: Pain, Acute

Treatments: Drug: S-Ibuprofen; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852459

AP-007

Details and patient eligibility

About

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

Full description

The purpose of this randomized, double-blind 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: 251 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• history of pain/soreness after exercise
• BMI between 18-30
• negative drug, alcohol, pregnancy screens
• other protocol-defined inclusion criteria may apply

Exclusion criteria

• upper extremity workout in last 3 months
• job or hobby requiring heavy lifting
• history of muscle disorders
• allergy or intolerance to NSAID or 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: Quadruple Blind

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251 participants in 2 patient groups, including a placebo group

Active Arm

Experimental group

Description:

S-Ibuprofen Topical Gel 5%

Treatment:

Drug: S-Ibuprofen

Placebo Arm

Placebo Comparator group

Description:

Vehicle Topical Gel

Treatment:

Drug: Vehicle