FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01037816 |
Recruitment Status :
Completed
First Posted : December 23, 2009
Last Update Posted : June 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ankle Sprain | Drug: FS-67 Patch Other: Placebo Patch | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 252 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: FS-67 patch
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
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Drug: FS-67 Patch
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Other Name: Topical Patch |
Placebo Comparator: Placebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
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Other: Placebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Other Name: Sham treatment |
- Primary: Sum of Pain Intensity Difference at 8-hours (SPID8) upon monopodal weight bearing. [ Time Frame: 8 hours ]
- SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [ Time Frame: 3 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Grade 1 or Grade 2 ankle sprain
Exclusion Criteria:
- Pregnancy or lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037816
United States, Alabama | |
Hisamitsu Investigator Site | |
Birmingham, Alabama, United States, 35209 | |
United States, Arizona | |
Hisamitsu Investigator Site | |
Tucson, Arizona, United States, 85705 | |
Hisamitsu Investigator Site | |
Tucson, Arizona, United States, 85712 | |
United States, Arkansas | |
Hisamitsu Investigator Site | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Hisamitsu Investigator Site | |
Anaheim, California, United States, 92804 | |
Hisamitsu Investigator Site | |
Bell Gardens, California, United States, 90201 | |
Hisamitsu Investigator Site | |
Long Beach, California, United States, 90806 | |
Hisamitsu Investigator Site | |
Los Angeles, California, United States, 90036 | |
United States, Florida | |
Hisamitsu Investigator Site | |
Boynton Beach, Florida, United States, 33472 | |
Hisamitsu Investigator Site | |
Daytona Beach, Florida, United States, 32117 | |
Hisamitsu Investigator Site | |
Doral, Florida, United States, 33166 | |
Hisamitsu Investigator Site | |
Jacksonville, Florida, United States, 32216 | |
United States, Indiana | |
Hisamitsu Investigator Site | |
Evansville, Indiana, United States, 47714 | |
United States, Kansas | |
Hisamitsu Investigator Site | |
Topeka, Kansas, United States, 66604 | |
United States, Nebraska | |
Hisamitsu Investigator Site | |
Bellevue, Nebraska, United States, 68005 | |
Hisamitsu Investigator Site | |
Lincoln, Nebraska, United States, 68510 | |
United States, Nevada | |
Hisamitsu Investigator Site | |
Las Vegas, Nevada, United States, 89106 | |
United States, New Jersey | |
Hisamitsu Investigator Site | |
Berlin, New Jersey, United States, 08009 | |
United States, North Carolina | |
Hisamitsu Investigator Site | |
Charlotte, North Carolina, United States, 28207 | |
United States, Ohio | |
Hisamitsu Investigator Site | |
Columbus, Ohio, United States, 43214 | |
Hisamitsu Investigator Site | |
Dayton, Ohio, United States, 45432 | |
United States, Texas | |
Hisamitsu Investigator Site | |
El Paso, Texas, United States, 79902 | |
Hisamitsu Investigator Site | |
Grapevine, Texas, United States, 76051 |
Responsible Party: | Hisamitsu Pharmaceutical Co., Inc. |
ClinicalTrials.gov Identifier: | NCT01037816 |
Other Study ID Numbers: |
FS-67-HP01-E02 |
First Posted: | December 23, 2009 Key Record Dates |
Last Update Posted: | June 4, 2015 |
Last Verified: | May 2015 |
Ankle Sprain |
Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries |