HKT-500 in the Treatment of Adult Patients With Ankle Sprain
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
1 other identifier
interventional
240
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2009
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 4, 2015
May 1, 2015
1.3 years
June 24, 2009
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
3 days + 1
Secondary Outcomes (1)
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
14 days
Study Arms (2)
Ketoprofen Patch (HKT-500)
ACTIVE COMPARATORTwo Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Placebo Patch
PLACEBO COMPARATORTwo placebo patches placed on target ankle once daily for 14 days
Interventions
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
Eligibility Criteria
You may qualify if:
- mild to Moderate Ankle Sprain
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Hisamitsu Investigator Site
Birmingham, Alabama, 35290, United States
Hisamitsu Investigator Site
Phoenix, Arizona, 85050, United States
Hisamitsu Investigator Site
Tucson, Arizona, 85712, United States
Hisamitsu Investigator Site
Hot Springs, Arkansas, 71913, United States
Hisamitsu Investigator Site
Anaheim, California, 92801, United States
Hisamitsu Investigator Site
Anaheim, California, 92804, United States
Hisamitsu Investigator Site
Buena Park, California, 90620, United States
Hisamitsu Investigator Site
Long Beach, California, 90813, United States
Hisamitsu Investigator Site
San Diego, California, 92120, United States
Hisamitsu Investigator Site
San Luis Obispo, California, 93405, United States
Hisamitsu Investigator Site
Daytona Beach, Florida, 32117, United States
Hisamitsu Investigator Site
Hialeah, Florida, 33013, United States
Hisamitsu Investigator Site
Jacksonville, Florida, 32216, United States
Hisamitsu Investigator Site
Lauderdale Lakes, Florida, 33319, United States
Hisamitsu Investigator Site
Oldsmar, Florida, 34677, United States
Hisamitsu Investigator Site
Ormond Beach, Florida, 32174, United States
Hisamitsu Investigator Site
South Miami, Florida, 33143, United States
Hisamitsu Investigator Site
Evansville, Indiana, 47714, United States
Hisamitsu Investigator Site
Omaha, Nebraska, 68114, United States
Hisamitsu Investigator Site
Blackwood, New Jersey, 08012, United States
Hisamitsu Investigator Site
South Bound Brook, New Jersey, 08880, United States
Hisamitsu Investigator Site
Johnson City, Tennessee, 37604, United States
Hisamitsu Investigator Site
Dallas, Texas, 75243, United States
Hisamitsu Investigator Site
West Valley City, Utah, 84120, United States
Hisamitsu Investigator Site
Danville, Virginia, 24541, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 25, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 4, 2015
Record last verified: 2015-05