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NCT01037816 · ClinicalTrials.gov registry record · Phase 4
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
A Phase 4 study of Ankle Sprain, sponsored by Hisamitsu Pharmaceutical Co..
- Completed
- Registry status
- Phase 4
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT01037816: Completed Phase 4 study of Ankle Sprain, sponsored by Hisamitsu Pharmaceutical Co..
NCT01037816 is a Phase 4 study of Ankle Sprain that has completed, run by Hisamitsu Pharmaceutical Co.. The registered enrollment target is 252 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037816, a Phase 4 study of Ankle Sprain, has completed, sponsored by Hisamitsu Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm r
Conditions Studied
Interventions
- DRUG FS-67 Patch
- OTHER Placebo Patch
Study Locations (20)
California
- Hisamitsu Investigator Site - Anaheim
- Hisamitsu Investigator Site - Bell Gardens
- Hisamitsu Investigator Site - Long Beach
- Hisamitsu Investigator Site - Los Angeles
Florida
- Hisamitsu Investigator Site - Boynton Beach
- Hisamitsu Investigator Site - Daytona Beach
- Hisamitsu Investigator Site - Doral
- Hisamitsu Investigator Site - Jacksonville
Arizona
- Hisamitsu Investigator Site - Tucson
- Hisamitsu Investigator Site - Tucson
Nebraska
- Hisamitsu Investigator Site - Bellevue
- Hisamitsu Investigator Site - Lincoln
Alabama
- Hisamitsu Investigator Site - Birmingham
Arkansas
- Hisamitsu Investigator Site - Hot Springs
Indiana
- Hisamitsu Investigator Site - Evansville
Kansas
- Hisamitsu Investigator Site - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT01037816 record still lists
NCT01037816 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Ankle Sprain appearing as the primary indexed condition, and to 2 interventions - of which FS-67 Patch is the first listed.
NCT01037816 names 20 study sites across 12 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01037816 about?
NCT01037816 is a clinical study titled "FS-67 in the Treatment of Pediatric Patients With Ankle Sprain". 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).
What is the current status of trial NCT01037816?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 252 participants. The study started on 2009-12. Estimated completion is 2010-12.
What conditions does trial NCT01037816 study?
This clinical trial studies the following conditions: Ankle Sprain.
What interventions are being tested in trial NCT01037816?
The interventions under investigation include: FS-67 Patch (DRUG), Placebo Patch (OTHER).
Who is sponsoring clinical trial NCT01037816?
This trial is sponsored by Hisamitsu Pharmaceutical Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037816 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01037816's enrollment target sits among peer trials
252 339th of 2000 higher than 1,659 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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