Status:
COMPLETED
HKT-500 in the Treatment of Adult Patients With Ankle Sprain
Lead Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
Conditions:
Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
Eligibility Criteria
Inclusion
- mild to Moderate Ankle Sprain
Exclusion
- Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00927641
Start Date
July 1 2009
End Date
November 1 2010
Last Update
June 4 2015
Active Locations (25)
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1
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35290
2
Hisamitsu Investigator Site
Phoenix, Arizona, United States, 85050
3
Hisamitsu Investigator Site
Tucson, Arizona, United States, 85712
4
Hisamitsu Investigator Site
Hot Springs, Arkansas, United States, 71913