Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries

Phase 4 Completed 104 enrolled IBSA Institut Biochimique SA

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2014-05
Primary completion: 2016-10
Completion: 2017-05

Publications

Jones CA, Hoehler FK, Frangione V, Ledesma G, Wisman PP Jr, Jones C. Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. Clin Drug Investig. 2022 Jan;42(1):43-51. doi: 10.1007/s40261-021-01101-x. Epub 2021 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	180 mg	Topical

Indications

No indication recorded.