Titre du document / Document title

Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet®) in treatment of chronic low back pain: A multicenter, outpatient, randomized, double blind, placebo controlled trial

Auteur(s) / Author(s)

Protocol TRP-CAN-1 Study Group, CANADA
PELOSO Paul M. ; FORTIN Luc ; BEAULIEU André ; KAMIN Marc ; ROSENTHAL Norman R. ;

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

Division of Rheumatology, Roy and Lucille Carver College of Medicine, University of Iowa Health Care, Iowa City, Iowa, ETATS-UNIS
Institut de Physiatrie du Québec, Montréal, Québec, CANADA
Centre Hospitalier Universitaire de Québec, Sainte-Foy, Québec, CANADA
Ortho-McNeil Pharmaceutical, Raritan, New Jersey, ETATS-UNIS

Résumé / Abstract

Objective. To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP). Methods. This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for ≥ 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores a 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. Results. In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as very good or good than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg). Conclusion. Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP.

Revue / Journal Title

Journal of rheumatology   ISSN 0315-162X   CODEN JRHUA9 

Source / Source

2004, vol. 31, n^o12, pp. 2454-2463 [10 page(s) (article)] (48 ref.)

Langue / Language

Anglais

Editeur / Publisher

Journal of Rheumatology Publishing, Toronto, ON, CANADA  (1974) (Revue)

Mots-clés anglais / English Keywords

Intestinal disease ; Digestive diseases ; Equilibrium disorder ; Nervous system diseases ; ENT disease ; Diseases of the osteoarticular system ; Spine disease ; Rachialgia ; Secondary ; Prognosis ; Primary ; Lumbar spine ; Pain ; Evaluation scale ; Analog ; Human ; Analgesia ; Double blind study ; Ambulatory ; Low back pain ; Chronic ; Method ; Treatment ; Tablet ; Paracetamol ; Tramadol ; Toxicity ; Analgesic ; Vertigo ;

Mots-clés français / French Keywords

Intestin pathologie ; Appareil digestif pathologie ; Trouble équilibre ; Système nerveux pathologie ; ORL pathologie ; Système ostéoarticulaire pathologie ; Rachis pathologie ; Rachialgie ; Secondaire ; Pronostic ; Primaire ; Rachis lombaire ; Douleur ; Echelle d'évaluation ; Analogue ; Homme ; Analgésie ; Etude double insu ; Ambulatoire ; Lombalgie ; Chronique ; Méthode ; Traitement ; Comprimé ; Paracétamol ; Tramadol ; Toxicité ; Analgésique ; Vertige ;

Mots-clés espagnols / Spanish Keywords

Intestino patología ; Aparato digestivo patología ; Trastorno equilibrio ; Sistema nervioso patología ; ORL patología ; Sistema osteoarticular patología ; Raquis patología ; Raquialgia ; Secundario ; Pronóstico ; Primario ; Raquis lumbar ; Dolor ; Escala evaluación ; Análogo ; Hombre ; Analgesia ; Estudio doble ciego ; Ambulatorio ; Lumbalgia ; Crónico ; Método ; Tratamiento ; Tableta ; Paracetamol ; Tramadol ; Toxicidad ; Analgésico ; Vértigo ;

Localisation / Location

INIST-CNRS, Cote INIST : 16024, 35400012133634.0260