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NCT02132247 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
A Phase 4 study of Athletic Injuries, sponsored by IBSA Institut Biochimique.
- Completed
- Registry status
- Phase 4
- Development phase
- 104
- Enrollment target
- 10
- Study locations
NCT02132247: Completed Phase 4 study of Athletic Injuries, sponsored by IBSA Institut Biochimique.
NCT02132247 is a Phase 4 study of Athletic Injuries that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 104 participants, below the 188-participant average among 3 other Athletic Injuries trials with a reported enrollment target (45% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02132247, a Phase 4 study of Athletic Injuries, has completed, sponsored by IBSA Institut Biochimique.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 104 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
Primary Outcome
None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.
Conditions Studied
Interventions
- DRUG Diclofenac hydroxyethylpyrrolidine
Study Locations (10)
Utah
- Utah Valley Pediatrics - Orem
- J. Lewis Research Inc./Foothill Family Clininc - Salt Lake City
- J. Lewis Research Inc./FirstMed East - Salt Lake City
- J. Lewis Research Inc./Foothill Family Clinic South - Salt Lake City
- Legacy Point Family Medicine - West Point
Arkansas
- Applied Research Center of Arkansas - Little Rock
Florida
- SCORE Physician Alliance - St. Petersburg
Georgia
- Pediatrics and Adolescent Medicine P.A. - Marietta
Texas
- Arlington Family Research Center Inc. - Arlington
Virginia
- Pediatric Research of Charlottesville - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-05 |
| Phase | Phase 4 |
What the finished NCT02132247 record still lists
NCT02132247 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 3 other Athletic Injuries trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Athletic Injuries appearing as the primary indexed condition, and to 1 intervention - of which Diclofenac hydroxyethylpyrrolidine is the first listed.
NCT02132247 lists 10 locations in 6 states (Utah, Arkansas, Florida).
Frequently Asked Questions
What is clinical trial NCT02132247 about?
NCT02132247 is a clinical study titled "Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries". The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
What is the current status of trial NCT02132247?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2014-05. Estimated completion is 2017-05.
What conditions does trial NCT02132247 study?
This clinical trial studies the following conditions: Athletic Injuries.
What interventions are being tested in trial NCT02132247?
The interventions under investigation include: Diclofenac hydroxyethylpyrrolidine (DRUG).
Who is sponsoring clinical trial NCT02132247?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02132247 being conducted?
This trial has 10 study locations across Arkansas, Florida, Georgia, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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