Tesfaye, Solomon
Saravanan, Ponnusamy
Ehler, Edvard
Zinek, Karel
Palka-Kisielowska, Ilona
Nastaj, Marcin
Serusclat, Pierre
Lipone, Paola
Vergallo, Andrea
Quarchioni, Elisa
Calisti, Fabrizio
Comandini, Alessandro
Cattaneo, Agnese
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study
https://doi.org/10.1007/s40122-024-00624-3
Article History
Received: 1 May 2024
Accepted: 3 June 2024
First Online: 24 June 2024
Declarations
:
: Solomon Tesfaye received: honoraria from Procter & Gamble, Viatris, Grunenthal, Novo Nordisk, Pfizer, Merck, Eva Pharma, Hikma, Astellas Pharma, Abbott, AstraZeneca, Berlin-Chemie, Worwag Pharma, Nevro, Haisco Pharmaceutical Group, for educational meetings; consultancy fees for advisor board membership from Angelini Pharma, Bayer, GSK, Worwag Phrama and Nevro; research equipment donated to Sheffield Teaching Hospitals from Impeto Medical and Neurometrix; and unrestricted, competitive research grants from Viatris and Procter and Gamble. Ponnusamy Saravanan was the Principal Investigator of the experimental center located in Nuneaton (United Kingdom) and has no conflict of interest. Edvard Ehler was the Principal Investigator of the experimental center located in Pardubice (Czech Republic) and has no conflict of interest. Karel Zinek was the Principal Investigator of the experimental center located in Litomyšl (Czech Republic) and has no conflict of interest. Ilona Palka-Kisielowska was the Principal Investigator of the experimental center located in Katowice (Poland) and has no conflict of interest. Marcin Nastaj was the Principal Investigator of the experimental center located in Lublin (Poland) and has no conflict of interest. Pierre Serusclat was the Principal Investigator of the experimental center located in Venissieux (France) and has no conflict of interest. Paola Lipone, Elisa Quarchioni, Fabrizio Calisti, Alessandro Comandini, Agnese Cattaneo are full-time employees in Angelini Pharma S.p.A. Andrea Vergallo was a full-time employee of Angelini Pharma S.p.A. at the time of the completion of the manuscript.
: The study was approved by the Competent Authorities and applicable Ethic Committees of Czech Republic (State Institute for Drug Control, Thomayerova nemocnice a IKEM, Ethics Committee Nemocnice Pardubického kraje a.s., Axon Clinical, Etická komise CLINTRIAL s.r.o.), France (ANSM Agence Nationale de Sécurité du Médicament et des produits de santé and Comité de Protection des Personnes (CPP) désigné par le système CNRIPH), Poland (Departament Badań Klinicznych Produktów Leczniczych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych and Komisja Bioetyczna przy Śląskiej Izbie Lekarskiej w Katowicach), and United Kingdom (Medicines and Healthcare products Regulatory Agency and East of England—Cambridgeshire and Hertfordshire Research Ethics Committee) and was conducted in accordance with Good Clinical Practice guideline and ethical standards as laid down in the 1964 Declaration of Helsinki. Written informed consent (including personal data processing) was obtained from all individual participants included in the study prior to starting any study-related procedure.