Jones, Christopher A.
Hoehler, Fred K.
Frangione, Valeria
Ledesma, Gilbert
Wisman, Paul P. Jr
Jones, Clarence
Clinical trials referenced in this document:
Documents that mention this clinical trial
Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial
https://doi.org/10.1007/s40261-021-01101-x
Funding for this research was provided by:
ibsa institut biochimique sa, pambio-noranco, switzerland
Article History
Accepted: 1 November 2021
First Online: 26 November 2021
Declarations
:
: This clinical trial was financially supported by IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
: FH is an IBSA consultant. At the time of the study, CAJ and CJ were employees of IBSA Pharma Inc., a wholly-owned subsidiary of IBSA. VF is an employee of IBSA CH. GL and PPW have no financial interests in either FDETS or IBSA CH or its affiliate.
: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
: CAJ: contributed to protocol design and study management, reviewed study data, authored the CSR, and reviewed/revised the manuscript. FH: prepared the study statistical analysis plan (SAP), oversaw study data management and analysis, provided additional statistical analysis for the manuscript, and reviewed/revised the manuscript. VF: reviewed the manuscript. GL and PPW: reviewed and executed the protocol and reviewed the manuscript. CJ: contributed to protocol design and study management, reviewed study data and the clinical study report (CSR), and reviewed/revised the manuscript.
: A central institutional review board approved the protocol at each participating site, and the study was conducted according to the ethical principles of human research established by the Declaration of Helsinki and its amendments.
: Informed consent by way of a Parental Permission Form was obtained in writing from parents/legally authorized representatives and, in addition, children aged 10–16 years were required to sign a Children’s Assent Form, before the commencement of study procedures.
: Not applicable.