Langford, Richard
Pogatzki-Zahn, Esther M.
Morte, Adelaida
Sust, Mariano
Cebrecos, Jesús
Vaqué, Anna
Ortiz, Esther
Fettiplace, James
Adeyemi, Shola
López-Cedrún, José Luis
Bescós, Socorro
Gascón, Neus
Plata-Salamán, Carlos
Clinical trials referenced in this document:
Documents that mention this clinical trial
Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
https://doi.org/10.1007/s12325-023-02744-2
Funding for this research was provided by:
Esteve Pharmaceuticals
Article History
Received: 16 October 2023
Accepted: 16 November 2023
First Online: 6 January 2024
Declarations
:
: Richard Langford has received fees from Pfizer, Eli Lilly, Compass, GSK, Avenue Therapeutics, MedinCell, Heron, Camurus, BioQ Pharma, Mundipharma, Grünenthal GmbH, Grünenthal Ltd and Syntetica for consultancy and speaker activities, and travel support from ESTEVE. Esther M. Pogatzki-Zahn received financial support for research activities, advisory board activities and lecture fees from Grünenthal, Medtronic, Mundipharma, and Novartis; she also receives scientific support from the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), the Federal Joint Committee (G-BA) and the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 777500. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation program and the European Federation of Pharmaceutical Industries and Associations. All money went to the institutions (WWU/UHM) where Esther M. Pogatzki-Zahn is employed. Adelaida Morte, Mariano Sust, Jesús Cebrecos, Anna Vaqué, Esther Ortiz, and Neus Gascón are employees of ESTEVE Pharmaceuticals. Socorro Bescós’s institution was paid commercial fees from Mundipharma Research GmbH & Co. KG for work on the study. Carlos Plata-Salamán was an employee of ESTEVE Pharmaceuticals and has pending or issued patents relevant to CTC. James Fettiplace and Shola Adeyemi were employees of Mundipharma Research Limited at the time of study. José Luis López-Cedrún has nothing to disclose.
: The study protocol was approved by the local ethics committee for each country and/or study site; the ethics committees included in this study are listed in the Supplementary Methods S1. The principal investigator was from Spain, and the Spanish ethics committee was the Comité Ético de Investigación Clínica con Medicamentos del Hospital Universitario de la Princesa (Madrid), resolution No. 20/17 of 10 November 2016. All patients provided written informed consent during the screening period of the study (i.e. before surgery). The study was conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines.