Lipone, Paola
Ehler, Edvard
Nastaj, Marcin
Palka-Kisielowska, Ilona
Cruccu, Giorgio
Truini, Andrea
Di Loreto, Giorgio
Del Vecchio, Alessandra
Pochiero, Ilena
Comandini, Alessandro
Calisti, Fabrizio
Cattaneo, Agnese
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study
https://doi.org/10.1007/s40263-020-00760-2
Article History
First Online: 16 September 2020
Declarations
:
: This study was sponsored by Angelini Pharma S.p.A. (S. Palomba, Pomezia, Rome, Italy). Open access funding provided by Università degli Studi di Roma La Sapienza within the CRUI-CARE Agreement
: Giorgio Cruccu received personal fees for advisory boards or consultancy from Angelini, Grunenthal, and Lilly, and personal fees for educational activity by PTS Global Services. Andrea Truini received honoraria for speaking at symposia or research financial supports from Alpha-Sigma, Angelini Pharma, Epitech, FB Health, Pfizer, and Grunenthal. Edvard Ehler has no conflicts of interest that are directly relevant to the content of this study; however, his institution received a fee for conducting the clinical trial from Angelini Pharma S.p.A. Marcin Nastaj and Ilona Palka-Kisielowska received principal investigator fees from Angelini Pharma S.p.A. Fabrizio Calisti, Agnese Cattaneo, Alessandro Comandini, Alessandra Del Vecchio, Giorgio Di Loreto, Paola Lipone, and Ilena Pochiero are full-time employees of Angelini Pharma S.p.A.
: The study was approved by the competent authorities and applicable ethics committees of Czech Republic, Hungary, and Poland and was conducted in accordance with Good Clinical Practice guidelines and ethical standards as laid down in the 1964 Declaration of Helsinki.
: All authors consent to the publication of the manuscript and accept the terms of related agreement.
: Written informed consent was obtained from all individual participants included in the study prior to starting any study-related procedure.
: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: Giorgio Cruccu, Andrea Truini, Paola Lipone, Alessandra Del Vecchio, Giorgio Di Loreto, Fabrizio Calisti, and Alessandro Comandini contributed to the study conception and design. Giorgio Di Loreto carried out the statistical analysis of the study. Edvard Ehler, Marcin Nastaj, and Ilona Palka-Kisielowska contributed to the study management and data collection. Ilena Pochiero supervised operational aspects of the trial and data collection. Agnese Cattaneo reviewed and commented on the study results. The first draft of the manuscript was written by Paola Lipone and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.