search
Back to results

HKT-500 in the Treatment of Adult Patients With Ankle Sprain

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketoprofen Patch
Placebo Patch
Sponsored by
Hisamitsu Pharmaceutical Co., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle Sprain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mild to Moderate Ankle Sprain

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketoprofen Patch (HKT-500)

Placebo Patch

Arm Description

Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Two placebo patches placed on target ankle once daily for 14 days

Outcomes

Primary Outcome Measures

Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)

Secondary Outcome Measures

Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction

Full Information

First Posted
June 24, 2009
Last Updated
May 12, 2015
Sponsor
Hisamitsu Pharmaceutical Co., Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00927641
Brief Title
HKT-500 in the Treatment of Adult Patients With Ankle Sprain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hisamitsu Pharmaceutical Co., Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle Sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketoprofen Patch (HKT-500)
Arm Type
Active Comparator
Arm Description
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Two placebo patches placed on target ankle once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Ketoprofen Patch
Other Intervention Name(s)
Topical Patch
Intervention Description
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Sham treatment
Intervention Description
Two placebo patches placed on target ankle once daily for 14 days
Primary Outcome Measure Information:
Title
Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)
Time Frame
3 days + 1
Secondary Outcome Measure Information:
Title
Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild to Moderate Ankle Sprain Exclusion Criteria: 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.
Facility Information:
Facility Name
Hisamitsu Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35290
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Hisamitsu Investigator Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
Hisamitsu Investigator Site
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Hisamitsu Investigator Site
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HKT-500 in the Treatment of Adult Patients With Ankle Sprain

We'll reach out to this number within 24 hrs