title: A comparison of the analgesic efficacy of Tramadol Contramid OAD versus placebo in patients with pain due to osteoarthritis.
abstract: One thousand twenty-eight (1,028) patients with pain due to osteoarthritis (OA) of the knee were enrolled in this multicenter, randomized, double-blind, parallel study designed to assess the analgesic efficacy and safety of Tramadol Contramid OAD compared to placebo. An open-label phase was followed by a double-blind phase, in which a total of 646 patients were randomized to double-blind treatment with placebo or Tramadol Contramid OAD. Patients were titrated to their optimal dose (200mg or 300 mg), which was maintained for 12 weeks. An absolute mean reduction of 3.0+/-2.1 on a Pain Intensity Numerical Rating Scale (PI-NRS) was noted in the Tramadol Contramid OAD treatment group. The difference between active and placebo groups regarding this absolute mean reduction was statistically significant (P<0.001) throughout the study. The responder analysis demonstrated that a significantly greater percentage of patients in the active treatment arm achieved a reduction of >or=1 and >or=2 points on the PI-NRS score by the end of the study (P=0.035). A significantly greater percentage of respondents in the Tramadol Contramid OAD group indicated improvement on both the Patient and Physician Global Impressions of Change (P=0.0002). Both the 200mg and 300 mg doses contributed to the overall superiority of Tramadol Contramid OAD. The most frequent adverse events were consistent with the known side effects of tramadol and were generally mild to moderate in intensity. These results confirm that Tramadol Contramid OAD given once daily is an efficacious and safe treatment for pain due to OA.
authors.affiliation: Radiant Research, San Antonio, Texas, USA.
authors.forename: Francis
authors.initials: F
authors.lastname: Burch
authors.forename: Ritchard
authors.initials: R
authors.lastname: Fishman
authors.forename: Nicholas
authors.initials: N
authors.lastname: Messina
authors.forename: Bruce
authors.initials: B
authors.lastname: Corser
authors.forename: Florin
authors.initials: F
authors.lastname: Radulescu
authors.forename: Adrian
authors.initials: A
authors.lastname: Sarbu
authors.forename: Marcela M
authors.initials: MM
authors.lastname: Craciun-Nicodin
authors.forename: Rodica
authors.initials: R
authors.lastname: Chiriac
authors.forename: André
authors.initials: A
authors.lastname: Beaulieu
authors.forename: Jude
authors.initials: J
authors.lastname: Rodrigues
authors.forename: Philippe
authors.initials: P
authors.lastname: Beignot-Devalmont
authors.forename: Alain
authors.initials: A
authors.lastname: Duplan
authors.forename: Sybil
authors.initials: S
authors.lastname: Robertson
authors.forename: Louise
authors.initials: L
authors.lastname: Fortier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bouchard
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D014147:Tramadol