Titre du document / Document title

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain

Auteur(s) / Author(s)

GAMMAITONI Arnold R. ⁽¹⁾ ; GALER Bradley S. ⁽¹⁾ ; BULLOCH Scott ⁽²⁾ ; LACOUTURE Peter ⁽³⁾ ; CARUSO Frank ⁽¹⁾ ; MA Tina ⁽¹⁾ ; SCHLAGHECK Thomas ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Endo Pharmaceuticals, Inc., Chadds Ford, Pennsylvania, ETATS-UNIS
⁽²⁾ Jean Brown Associates, St. George, Utah, ETATS-UNIS
⁽³⁾ Magidom Discovery, LLC, Westport, Connecticut, ETATS-UNIS

Résumé / Abstract

This randomized, controlled trial compared the analgesic efficacy and safety of the new oxycodone 10-mg/ acetaminophen 325-mg formulation (Percocet®) for the treatment of acute pain following oral surgery with double the dose of oxycodone alone (controlled-release [CR] oxycodone 20 mg [Oxycontin®]). A total of 150 male and female patients with > 2 full or partial bone-impacted mandibular molars, at least moderate persistent pain, and moderate trauma received a single dose of combination agent, CR oxycodone, or placebo following oral surgery and rated pain intensity and pain relief over the next 6 hours. The intent-to-treat population comprised 141 patients (55 on combination agent, 56 on oxycodone, and 30 on placebo). Combination agent and CR oxycodone were significantly superior to placebo for all efficacy measures. Combination agent was statistically superior to CR oxycodone in four of five outcome measures of pain intensity and pain relief(PPID, PPAR, SPID, and SPRID). It also provided a faster onset and 24% reduction in the number of patients reporting treatment-related adverse events compared with twice the dose of opioid alone. This new formulation offers the combination of two analgesic drugs with complementary mechanisms of action, which results in enhanced analgesia, an opioid-sparing effect, and an improved side effect and safety profile.

Revue / Journal Title

Journal of clinical pharmacology   ISSN 0091-2700   CODEN JCPCBR 

Source / Source

2003, vol. 43, n^o3, pp. 296-304 [9 page(s) (article)] (27 ref.)

Langue / Language

Anglais

Editeur / Publisher

Sage Science, Thousand Oaks, CA, ETATS-UNIS  (1973) (Revue)

Mots-clés anglais / English Keywords

Controlled therapeutic trial ; Opiates ; Toxicity ; Comparative study ; Human ; Single dose ; Oral administration ; Surgery ; Pain ; Biological activity ; Controlled release form ; Dosage form ; Formulation ; Drug combination ; Analgesic ; Narcotic analgesic ; Paracetamol ; Oxycodone ;

Mots-clés français / French Keywords

Essai thérapeutique contrôlé ; Opiacés ; Toxicité ; Etude comparative ; Homme ; Dose unique ; Voie orale ; Chirurgie ; Douleur ; Activité biologique ; Forme libération contrôlée ; Forme pharmaceutique ; Formulation ; Association médicamenteuse ; Analgésique ; Analgésique narcotique ; Paracétamol ; Oxycodone ;

Mots-clés espagnols / Spanish Keywords

Ensayo terapéutico controlado ; Opiados ; Toxicidad ; Estudio comparativo ; Hombre ; Dosis única ; Vía oral ; Cirugía ; Dolor ; Actividad biológica ; Forma liberación controlada ; Forma farmacéutica ; Formulación ; Asociación medicamentosa ; Analgésico ; Analgésico narcotico ; Paracetamol ; Oxicodona ;

Localisation / Location

INIST-CNRS, Cote INIST : 10257, 35400010417666.0110