Document Classification

Section Type: RESULTS

Text: Compared with placebo, this analysis found a significant improvement from baseline to the final visit in the co-primary efficacy variables of pain (least-squares [LS] mean [SE], 108. 7 [16. 9] ; P < or = 0. 05) and physical function (LS mean [SE], 366. 4 [57. 7] ; P < or = 0. 05) subscale scores of the WOMAC Osteoarthritis Index ; the patient global assessment of disease activity (LS mean [SE], 27. 9 [3. 9] ; P < or = 0. 01) for the tramadol ER 300-mg group ; and for the pain-related sleep effects for less awakenings by pain in the morning (100 -, 200 -, and 300-mg groups ; P < or = 0. 05), less awakenings by pain during the night (200 - and 300-mg groups ; P < or = 0. 035), significantly better overall sleep quality (200-mg group only ; P = 0. 037), and less trouble falling asleep due to pain (200-mg group only ; P = 0. 025).