HKT-500 in Adult Patients With Ankle Sprain

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.
• Treatments: Ketoprofen

Criteria

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.