Status:
COMPLETED
HKT-500 in 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
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...
Eligibility Criteria
Inclusion
- Grade I or Grade II Ankle Sprain.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00680784
Start Date
April 1 2008
End Date
November 1 2008
Last Update
June 4 2015
Active Locations (30)
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1
Hisamitsu Investigator Site.
Birmingham, Alabama, United States, 35209
2
Hisamitsu Investigator Site.
Birmingham, Alabama, United States, 35234
3
Hisamitsu Investigator Site.
Montgomery, Alabama, United States, 36106
4
Hisamitsu Investigator Site.
Anaheim, California, United States, 92804