Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.