NCT01874626

Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain

A Randomized, Double-blind, Placebo-controlled, Multi-dose, Pivotal Study to Determine the Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Strategic Science & Technologies, LLC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study and will receive either the active treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount equivalent to a 4 inch line of investigational product to the affected ankle approximately every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a 24 hour period. Duration of treatment with the investigational product is 7 days.

Conditions

• Acute Ankle Sprain

Interventions

Type	Name	Description
DRUG	Placebo	Placebo cream
DRUG	SST-0225 Topical Ibuprofen Cream	SST-0225 Topical Ibuprofen Cream

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-06-11
• Last updated: 2021-05-21

Locations

1 site across 1 country: United States