Trials / Completed
CompletedNCT02132247
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- IBSA Institut Biochimique SA · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diclofenac hydroxyethylpyrrolidine |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2016-10-01
- Completion
- 2017-05-01
- First posted
- 2014-05-07
- Last updated
- 2018-05-11
- Results posted
- 2018-05-11
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02132247. Inclusion in this directory is not an endorsement.