Viscusi, Eugene R. http://orcid.org/0000-0003-0260-4396
Langford, Richard http://orcid.org/0000-0002-8703-067X
Morte, Adelaida http://orcid.org/0000-0002-3897-8966
Vaqué, Anna http://orcid.org/0000-0001-9799-4619
Cebrecos, Jesús http://orcid.org/0000-0003-0238-8638
Sust, Mariano http://orcid.org/0000-0003-1908-9271
Giménez-Arnau, José María http://orcid.org/0009-0003-2675-4919
de Leon-Casasola, Oscar http://orcid.org/0000-0002-0837-9196
Clinical trials referenced in this document:
Documents that mention this clinical trial
Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials
https://doi.org/10.1007/s40122-024-00655-w
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
Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials
https://doi.org/10.1007/s40122-024-00655-w
Documents that mention this clinical trial
Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials
https://doi.org/10.1007/s40122-024-00655-w
Funding for this research was provided by:
Esteve Pharmaceuticals
Article History
Received: 10 July 2024
Accepted: 27 August 2024
First Online: 24 September 2024
Declarations
:
: Eugene R. Viscusi reports consulting fees from ESTEVE Pharmaceuticals, Heron Therapeutics, Merck, Orion Pharma, Salix Pharmaceuticals, and Vertex Pharmaceuticals. Richard Langford reports consulting and speaker fees from Avenue Therapeutics, BioQ Pharma, Camurus, Compass, Eli Lilly, Grünenthal GmbH, Grünenthal Ltd, GSK, Heron Therapeutics, Medincell, Mundipharma, Pfizer, and Sintetica. Adelaida Morte, Anna Vaqué, Jesús Cebrecos, Mariano Sust, and José María Giménez-Arnau are employees of ESTEVE Pharmaceuticals. Oscar de Leon-Casasola reports personal fees for advisory board membership from ESTEVE Pharmaceuticals during the conduct of the study, and from ESTEVE Pharmaceuticals, Merck, and Stimgenics Medtronic outside of the submitted work.
: All trials were conducted in compliance with Good Clinical Practice guidelines and the Declaration of Helsinki, and all trials received appropriate local ethics committee approval. All patients provided written informed consent. The ESTEVE-SUSA-301 protocol was approved by an Institutional Review Board, Sterling IRB (Atlanta, GA; IRB ID: 5724). The STARDOM1 study protocol was approved by the local ethics committee for each country and/or study site. 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. The STARDOM2 study protocol was reviewed and approved by local ethics committees and all concerned competent authorities for each country and/or study site. The principal investigator was from Poland, and the Polish ethics committee was the Bioethics Committee at the Poznan University of Medical Sciences, resolution no. 17/02 of 5 January 2017.