At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 104 enrolled
Drug / intervention
Diclofenac hydroxyethylpyrrolidinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries
In Brief
A Phase 4 clinical trial evaluating Diclofenac hydroxyethylpyrrolidine for Athletic Injuries. Completed, enrolled 104 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAthletic Injuries
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionOct 2016
Study CompletionMay 2017
TodayJul 2026
First PostedMay 7, 2014
Enrollment StartMay 1, 2014
Primary CompletionOct 1, 2016
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.2 years ago
Interventions
Diclofenac hydroxyethylpyrrolidinedrug