HKT-500 in Adult Patients With Ankle Sprain
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
1 other identifier
interventional
260
1 country
30
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 Apr 2008
Shorter than P25 for phase_3
30 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
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJune 4, 2015
May 1, 2015
7 months
May 16, 2008
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Assessment
2 Weeks
Secondary Outcomes (1)
Safety Assessment
2 Weeks
Study Arms (2)
HKT-500 Ketoprofen Topical Patch
EXPERIMENTALRandomized, 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.
Placebo Patch
PLACEBO COMPARATORTreatment with placebo patch
Interventions
HKT-500 Ketoprofen Topical Patch
Eligibility Criteria
You may qualify if:
- Grade I or Grade II Ankle Sprain.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Hisamitsu Investigator Site.
Birmingham, Alabama, 35209, United States
Hisamitsu Investigator Site.
Birmingham, Alabama, 35234, United States
Hisamitsu Investigator Site.
Montgomery, Alabama, 36106, United States
Hisamitsu Investigator Site.
Anaheim, California, 92804, United States
Hisamitsu Investigator Site.
San Luis Obispo, California, 93405, United States
Hisamitsu Investigator Site.
Colorado Springs, Colorado, 80909, United States
Hisamitsu Investigator Site.
Kissimmee, Florida, 34741, United States
Hisamitsu Investigator Site.
Oldsmar, Florida, 34677, United States
Hisamitsu Investigator Site.
Pembroke Pines, Florida, 33026, United States
Hisamitsu Investigator Site.
South Miami, Florida, 33143, United States
Hisamitsu Investigator Site.
Blue Ridge, Georgia, 30513, United States
Hisamitsu Investigator Site.
Chicago, Illinois, 60616, United States
Hisamitsu Investigator Site.
Paducah, Kentucky, 42003, United States
Hisamitsu Investigator Site.
Pasadena, Maryland, 21122, United States
Hisamitsu Investigator Site.
Benzonia, Michigan, 49616, United States
Hisamitsu Investigator Site.
Cadillac, Michigan, 49601, United States
Hisamitsu Investigator Site.
Interlochen, Michigan, 49643, United States
Hisamitsu Investigator Site.
Kalamazoo, Michigan, 49009, United States
Hisamitsu Investigator Site.
Omaha, Nebraska, 68114, United States
Hisamitsu Investigator Site.
South Bound Brook, New Jersey, 08880, United States
Hisamitsu Investigator Site.
Albuquerque, New Mexico, 87102, United States
Hisamitsu Investigator Site.
New York, New York, 10022, United States
Hisamitsu Investigator Site.
Fargo, North Dakota, 58103, United States
Hisamitsu Investigator Site.
Zanesville, Ohio, 43701, United States
Hisamitsu Investigator Site.
Altoona, Pennsylvania, 16602, United States
Hisamitsu Investigator Site.
Feasterville, Pennsylvania, 19053, United States
Hisamitsu Investigator Site.
Morrisville, Pennsylvania, 19067, United States
Hisamitsu Investigator Site.
Norristown, Pennsylvania, 19401, United States
Hisamitsu Investigator Site.
Houston, Texas, 77074, United States
Hisamitsu Investigator Site.
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenichi Furuta
Hisamitsu Pharmaceutical Co., Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
June 4, 2015
Record last verified: 2015-05