FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
This study has been completed.
Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
Information provided by:
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT01037816
First received: December 18, 2009
Last updated: February 9, 2011
Last verified: February 2011
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Purpose
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
| Condition | Intervention | Phase |
|---|---|---|
|
Ankle Sprain |
Drug: FS-67 Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:
Primary Outcome Measures:
- Primary: Sum of Pain Intensity Difference at 8-hours (SPID8) upon monopodal weight bearing. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: FS-67 |
Drug: FS-67
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
| Placebo Comparator: Placebo |
Other: Placebo
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Grade 1 or Grade 2 ankle sprain
Exclusion Criteria:
- Pregnancy or lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037816
Locations
| 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 | |
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
More Information
No publications provided
| Responsible Party: | Hisamitsu Pharmaceutical Co., Inc (Mr. Yoshinobu Higashi), Hisamitsu Pharmaceutical Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT01037816 History of Changes |
| Other Study ID Numbers: | FS-67-HP01-E02 |
| Study First Received: | December 18, 2009 |
| Last Updated: | February 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
|
Ankle Sprain |
Additional relevant MeSH terms:
|
Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries Capsaicin Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013