Treatment of chronic moderate-to-severe non-malignant pain with polymer-coated extended-release morphine sulfate capsules.

ABSTRACTObjective: To demonstrate the efficacy and tolerability of polymer-coated extended-release morphine sulfate (P-ERMS) (KADIAN) for the treatment of chronic, moderate-to-severe, non-malignant pain in a community-based outpatient population not satisfactorily relieved with their current therapies. * KADIAN is a registered trademark of Alpharma Branded Products Division Inc., Piscataway, NJDesign: Phase IV, prospective, randomized, open-label, blinded endpoint.Participants: Adults (N = 1428) with chronic, moderate-to-severe, non-malignant pain with visual numeric scale scores ≥ 4 (0 = no pain; 10 = worst pain).Interventions: Patients were randomized to P‐ERMS once daily in am or pm for a 4‐week treatment period. Dose increases were allowed; however, switching to twice-daily dosing was reserved until week 2.Main outcome measures: Improvement from baseline in pain and sleep scales (0–10) (after weeks 2 and 4), quality of life (physical and mental component summary scores of the SF-36v2 Health Survey) (w...