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Co-crystal of tramadol–celecoxib in patients with moderate to severe acute post-surgical oral pain: a dose-finding, randomised, double-blind, placebo- and active-controlled, multicentre, phase II trial
dc.contributor.author | López-Cedrún, José | |
dc.contributor.author | Videla, Sebastián | |
dc.contributor.author | Burgueño, Miguel | |
dc.contributor.author | Juárez, Inma | |
dc.contributor.author | Aboul-Hosn Centenero, Samir Carlos | |
dc.contributor.author | Martín-Granizo, Rafael | |
dc.contributor.author | Grau, Joan | |
dc.contributor.author | Puche, Miguel | |
dc.contributor.author | Gil-Diez, José-Luis | |
dc.contributor.author | Hueto Madrid, Juan Antonio | |
dc.contributor.author | vaqué, anna | |
dc.contributor.author | Sust, Mariano | |
dc.contributor.author | Plata-Salamán, Carlos | |
dc.contributor.author | Monner, Antoni | |
dc.contributor.author | Co-Crystal of Tramadol-Celecoxib Team | |
dc.date.accessioned | 2022-01-19T18:10:05Z | |
dc.date.available | 2022-01-19T18:10:05Z | |
dc.date.issued | 2018 | |
dc.identifier.citation | López-Cedrún, José; Videla, Sebastián; Burgueño, Miguel [et al.]. Co-crystal of tramadol–celecoxib in patients with moderate to severe acute post-surgical oral pain: a dose-finding, randomised, double-blind, placebo- and active-controlled, multicentre, phase II trial. Drugs in R&D, 2018, 18, p. 137–148. Disponible en: <https://link.springer.com/article/10.1007%2Fs40268-018-0235-y>. Fecha de acceso: 19 ene. 2022. DOI: 10.1007/s40268-018-0235-y | ca |
dc.identifier.issn | 1174-5886 | ca |
dc.identifier.uri | http://hdl.handle.net/20.500.12328/3087 | |
dc.description.abstract | Background: Co-crystal of tramadol–celecoxib (CTC), containing equimolar quantities of the active pharmaceutical ingredients (APIs) tramadol and celecoxib (100 mg CTC = 44 mg rac–tramadol hydrochloride and 56 mg celecoxib), is a novel API-API co-crystal for the treatment of pain. We aimed to establish the effective dose of CTC for treating acute pain following oral surgery. Methods: A dose-finding, double-blind, randomised, placebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778-21) was performed in male and female patients aged ≥ 18 years experiencing moderate to severe pain following extraction of two or more impacted third molars requiring bone removal. Eligible patients were randomised via a computer-generated list to receive one of six single-dose treatments (CTC 50, 100, 150, 200 mg; tramadol 100 mg; and placebo). The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 8 h assessed in the per-protocol population. Results: Between 10 February 2012 and 13 February 2013, 334 patients were randomised and received study treatment: 50 mg (n = 55), 100 mg (n = 53), 150 mg (n = 57), or 200 mg (n = 57) of CTC, 100 mg tramadol (n = 58), or placebo (n = 54). CTC 100, 150, and 200 mg showed significantly higher efficacy compared with placebo and/or tramadol in all measures: SPID (0–8 h) (mean [standard deviation]): − 90 (234), − 139 (227), − 173 (224), 71 (213), and 22 (228), respectively. The proportion of patients experiencing treatment-emergent adverse events was lower in the 50 (12.7% [n = 7]), 100 (11.3% [n = 6]), and 150 (15.8% [n = 9]) mg CTC groups, and similar in the 200 mg (29.8% [n = 17]) CTC group, compared with the tramadol group (29.3% [n = 17]), with nausea, dizziness, and vomiting the most frequent events. Conclusion: Significant improvement in the benefit–risk ratio was observed for CTC (doses ≥ 100 mg) over tramadol and placebo in the treatment of acute pain following oral surgery. | en |
dc.format.extent | 12 | ca |
dc.language.iso | eng | ca |
dc.publisher | Springer Nature | ca |
dc.relation.ispartof | Drugs in R&D | ca |
dc.relation.ispartofseries | 18; | |
dc.rights | This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. | en |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | |
dc.subject.other | Dolor oral postquirúrgic | ca |
dc.subject.other | Tractament del dolor | ca |
dc.subject.other | Cirurgia oral | ca |
dc.subject.other | Dolor oral postquirúrgico | es |
dc.subject.other | Tratamiento del dolor | es |
dc.subject.other | Cirugía oral | es |
dc.subject.other | Postoperative oral pain | en |
dc.subject.other | Pain treatment | en |
dc.subject.other | Oral surgery | en |
dc.title | Co-crystal of tramadol–celecoxib in patients with moderate to severe acute post-surgical oral pain: a dose-finding, randomised, double-blind, placebo- and active-controlled, multicentre, phase II trial | en |
dc.type | info:eu-repo/semantics/article | ca |
dc.description.version | info:eu-repo/semantics/publishedVersion | ca |
dc.rights.accessLevel | info:eu-repo/semantics/openAccess | |
dc.embargo.terms | cap | ca |
dc.subject.udc | 616.3 | ca |
dc.identifier.doi | https://dx.doi.org/10.1007/s40268-018-0235-y | ca |
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