Results of a Double‐blind, Placebo‐controlled, Fixed‐dose Assessment of Once‐daily OROS^® Hydromorphone ER in Patients with Moderate to Severe Pain Associated with Chronic Osteoarthritis

Abstract

OROS hydromorphone ER failed to achieve statistical significance for the primary endpoint using the prespecified imputation method (BOCF), likely due to the high discontinuation rate associated with the fixed-dose design. When data were analyzed according to an alternate method of imputation (LOCF), OROS hydromorphone ER demonstrated statistically significant improvements in pain, stiffness, and physical function.