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)

Autor: Giustino Varrassi, Magdi Hanna, Stefano Coaccioli, Paolo Fabrizzi, Simone Baldini, Ivan Kruljac, Carles Brotons, Serge Perrot
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Pain and Therapy, Vol 13, Iss 4, Pp 1007-1022 (2024)
Druh dokumentu: article
ISSN: 2193-8237
2193-651X
DOI: 10.1007/s40122-024-00623-4
Popis: 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 > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61). Results The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score
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