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DC Field | Value | Language |
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dc.contributor.author | López Cedrún, José | - |
dc.contributor.author | Videla, Sebas | - |
dc.contributor.author | Burgueño, Miguel | - |
dc.contributor.author | Juárez, Inma | - |
dc.contributor.author | Aboul-Hosn, Samir | - |
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, José 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 | 2020-12-01T15:33:29Z | - |
dc.date.available | 2020-12-01T15:33:29Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1174-5886 | - |
dc.identifier.uri | http://hdl.handle.net/2445/172495 | - |
dc.description.abstract | Background Co-crystal of tramadol-celecoxib (CTC), containing equimolar quantities of the active pharmaceu- tical 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, pla- cebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778- 21) was performed in male and female patients aged C 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 treat- ment: 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, dizzi- ness, and vomiting the most frequent events. Conclusion Significant improvement in the benefit-risk ratio was observed for CTC (doses C 100 mg) over tra- madol and placebo in the treatment of acute pain following oral surgery. | - |
dc.format.extent | 12 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Adis International | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1007/s40268-018-0235-y | - |
dc.relation.ispartof | Drugs in R&D, 2018, vol. 18, num. 2, p. 137-148 | - |
dc.relation.uri | https://doi.org/10.1007/s40268-018-0235-y | - |
dc.rights | cc-by-nc (c) López Cedrún, José et al., 2018 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es | - |
dc.source | Articles publicats en revistes (Patologia i Terapèutica Experimental) | - |
dc.subject.classification | Tractament del dolor | - |
dc.subject.classification | Dolor postoperatori | - |
dc.subject.classification | Dolor orofacial | - |
dc.subject.other | Pain treatment | - |
dc.subject.other | Postoperative pain | - |
dc.subject.other | Orofacial pain | - |
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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 697977 | - |
dc.date.updated | 2020-12-01T15:33:29Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 29799099 | - |
Appears in Collections: | Articles publicats en revistes (Patologia i Terapèutica Experimental) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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