HKT-500 in Adult Patients With Ankle Sprain

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680784
• Other study ID #: HKT-500-US10
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: May 12, 2015
• Start date: April 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2015
• Source: Hisamitsu Pharmaceutical Co., Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• HKT-500 Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch

Other:
• Placebo Patch
Placebo Patch

Locations

Country	Name	City	State
United States	Hisamitsu Investigator Site.	Albuquerque	New Mexico
United States	Hisamitsu Investigator Site.	Altoona	Pennsylvania
United States	Hisamitsu Investigator Site.	Anaheim	California
United States	Hisamitsu Investigator Site.	Bellevue	Washington
United States	Hisamitsu Investigator Site.	Benzonia	Michigan
United States	Hisamitsu Investigator Site.	Birmingham	Alabama
United States	Hisamitsu Investigator Site.	Birmingham	Alabama
United States	Hisamitsu Investigator Site.	Blue Ridge	Georgia
United States	Hisamitsu Investigator Site.	Cadillac	Michigan
United States	Hisamitsu Investigator Site.	Chicago	Illinois
United States	Hisamitsu Investigator Site.	Colorado Springs	Colorado
United States	Hisamitsu Investigator Site.	Fargo	North Dakota
United States	Hisamitsu Investigator Site.	Feasterville	Pennsylvania
United States	Hisamitsu Investigator Site.	Houston	Texas
United States	Hisamitsu Investigator Site.	Interlochen	Michigan
United States	Hisamitsu Investigator Site.	Kalamazoo	Michigan
United States	Hisamitsu Investigator Site.	Kissimmee	Florida
United States	Hisamitsu Investigator Site.	Montgomery	Alabama
United States	Hisamitsu Investigator Site.	Morrisville	Pennsylvania
United States	Hisamitsu Investigator Site.	New York	New York
United States	Hisamitsu Investigator Site.	Norristown	Pennsylvania
United States	Hisamitsu Investigator Site.	Oldsmar	Florida
United States	Hisamitsu Investigator Site.	Omaha	Nebraska
United States	Hisamitsu Investigator Site.	Paducah	Kentucky
United States	Hisamitsu Investigator Site.	Pasadena	Maryland
United States	Hisamitsu Investigator Site.	Pembroke Pines	Florida
United States	Hisamitsu Investigator Site.	San Luis Obispo	California
United States	Hisamitsu Investigator Site.	South Bound Brook	New Jersey
United States	Hisamitsu Investigator Site.	South Miami	Florida
United States	Hisamitsu Investigator Site.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment		2 Weeks	No
Secondary	Safety Assessment		2 Weeks	Yes