Varrassi, Giustino http://orcid.org/0000-0002-3822-2923
Hanna, Magdi
Coaccioli, Stefano
Fabrizzi, Paolo
Baldini, Simone
Kruljac, Ivan
Brotons, Carles
Perrot, Serge
Clinical trials referenced in this document:
Documents that mention this clinical trial
Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE)
https://doi.org/10.1007/s40122-024-00623-4
Funding for this research was provided by:
Menarini Group
Article History
Received: 25 April 2024
Accepted: 31 May 2024
First Online: 26 June 2024
Declarations
:
: Giustino Varrassi, Magdi Hanna, and Serge Perrot have received honoraria and consultancy fees from Menarini. Giustino Varrassi is a member of the Editorial Board of<i> Pain & Therapy</i>, but was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Stefano Coaccioli has received consultancy fees from Menarini. Ivan Kruljac and Carlos Brotons have no conflicts of interest to report. Paolo Fabrizzi and Simone Baldini are employed by A. Menarini Industrie Farmaceutiche Riunite, Florence, Italy.
: This study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practices (GCP), including the archiving of essential documents, as well as the ethical principles of the Declaration of Helsinki of 1964 and its later amendments. The study protocol and protocol amendments, patient information leaflet, informed consent form (ICF), Summary of Product Characteristics (SmPC), and any other relevant documents according to National Regulations were reviewed and approved by an independent ethics committee (IECs) and the Health Authorities (HAs) of the participating countries. All local, national, and legal requirements for the conduct of a clinical study were followed. Prior to the patient’s enrollment into the study and before performing any study-related procedures, the Investigator or its authorized delegate obtained the patient’s written, dated, and signed informed consent to participate in the study and to allow the confidential disclosure, processing, and transferring of necessary documentation of the patient’s health and personal data to the contract research organization (CRO), Sponsor and its Affiliates, the competent HAs, and any other institutions, as legally required and in accordance with the local applicable privacy laws.