Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid® OAD)

摘要: This placebo-controlled study examined the analgesic efficacy, safety, and clinical benefit of Tramadol Contramid OAD, a once-daily formulation with both immediate- extended-release components. Five hundred fifty-two patients moderate to severe pain due osteoarthritis (OA) knee were randomized into this multicenter, double-blind, parallel arm study. After randomization OAD 100, 200, or 300 mg, placebo, patients' dose was titrated fixed maintained for 12 weeks. Efficacy evaluated Patients' Global Rating Pain Relief (median ratings at maintenance visits), Western Ontario McMaster University (WOMAC) Physical Function subscales (percent difference, baseline end study) as coprimary endpoints. A responder analysis conducted (percentage who achieved 30 percent improvement on their WOMAC score). The difference from placebo median Patient four visits statistically significant (200 mg: p < = 0.001). Treatment rated effective very by 75 80 200 mg respectively. There 46 (300-mg dose; 0.016) 43 (200-mg 0.05) score (baseline compared 32percent placebo. demonstrated in percentage (65 percent; 0.0095) 0.0104) (50 percent). type incidence adverse events typical tramadol (nausea, dizziness/vertigo, vomiting, somnolence, constipation) intensity mild 87percent experienced them regardless dose. shows efficacy safety OA.