Aponia Laboratories, Inc.
Phase 3 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in treatment of pain in acute contusions of the soft tissues following blunt trauma.
Inclusion Criteria: 1. Acute soft-tissue injury/contusion. 2. Enrollment within 6 hours of the injury. 3. Baseline NRS score for POM of injured location \>5 score points on an 11-point NRS. 4. Size of injury, as assessed by the investigator, ≥25 cm2 and ≤120 cm2 5. Adult male or female patients aged ≥18 years. 6. Having given written informed consent. 7. Satisfactory health as determined by the investigator based on medical history and physical examination. Exclusion Criteria: 1. Significant concomitant injury in association with the acute injury; e.g., fracture, nerve injury, ligament disr…
Topical gel containing active ingredient S-ibuprofen
Placebo gel matching the active comparator in conposition and appearance without the active ingredient