February 10, 2010
Phase 3 study of MoxDuo IR for pain managementQRxPharma Limited announced initiation of a second Phase 3 registration trial (Study 009) to evaluate its MoxDuo IR (morphine and oxycodone) product for the management of moderate to severe pain in patients who have undergone total knee replacement surgery. This study is a randomized, double blind trial targeted to enroll 140 patients (70 per study Arm) at 8 U.S. clinical research sites. The primary endpoint for evaluating the efficacy of flexible dose versus low dose is the difference from baseline in pain intensity scores for each treatment group over the 48-hour treatment period [Sum of Pain Intensity Differences over 48 hours (SPID(48)) calculated using the 10-point Numerical Pain Rating Scale]. Secondary endpoints include: (1) efficacy relating to the time to onset of analgesia and global assessment of effect (i.e. total pain relief) as well as amount of supplemental analgesia used throughout the treatment period; and (2) safety as measured by incidence and intensity of opioid-related adverse effects.
MoxDuo IR is a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.
For more information call (908) 506-2900 or visit www.QRxPharma.com.