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)
Varrassi, G. (Paolo Procacci Foundation)
Hanna, M. (Analgesics and Pain Research (APR) Ltd)
Coaccioli, S. (European League Against Pain)
Fabrizzi, P. (A. Menarini Industrie Farmaceutiche Riunite S.r.l.)
Baldini, S. (A. Menarini Industrie Farmaceutiche Riunite S.r.l.)
Kruljac, I. (Poliklinika SOLMED d.o.o.)
Brotons, Carlos (Institut de Recerca Sant Pau)
Perrot, S. (Pain Center. INSERM U987. Hôpital Cochin. University of Paris)
Universitat Autònoma de Barcelona

Date:	2024
Abstract:	Introduction: Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE). Methods: A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Acute low back pain ; Clinical trial ; Dexketoprofen trometamol ; Fixed-dose combination ; Tramadol hydrochloride
Published in:	Pain and Therapy, Vol. 13 Núm. 4 (august 2024) , p. 1007-1022, ISSN 2193-651X

DOI: 10.1007/s40122-024-00623-4
PMID: 38922520

16 p, 1.3 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
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