NCT00680784

HKT-500 in Adult Patients With Ankle Sprain

Protocol HKT-500-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Hisamitsu Pharmaceutical Co., Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Detailed description

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	HKT-500 Ketoprofen Topical Patch	HKT-500 Ketoprofen Topical Patch
OTHER	Placebo Patch	Placebo Patch

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-05-20
• Last updated: 2015-06-04

Locations

30 sites across 1 country: United States