HKT-500 in Adult Patients With Ankle Sprain

Phase 3

Completed

• Conditions: Ankle Sprain
• Interventions: Drug: HKT-500 Ketoprofen Topical Patch; Other: Placebo Patch

• Registration Number: NCT00680784
• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Brief 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Disposition First Submitted: 2015-03-17
• Status Verified: 2015-05
• Disposition First Submitted QC: 2015-05-12
• Last Update Submitted: 2015-05-12
• Disposition First Posted: 2015-06-04
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Grade I or Grade II Ankle Sprain.

Exclusion Criteria

• The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HKT-500 Ketoprofen Topical Patch	HKT-500 Ketoprofen Topical Patch	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.
Placebo Patch	Placebo Patch	Treatment with placebo patch

Primary Outcome Measures

Name	Time	Method
Pain Assessment	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	2 Weeks

Trial Locations

Locations (1)

Hisamitsu Investigator Site.; 🇺🇸 Bellevue, Washington, United States