Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an established oxycodone twice daily prolonged release tablet.

Objective: The first oxycodone once daily (OOD) has been developed and after successful pharmacokinetic characterization, therapeutic efficacy and safety were compared to an established oxycodone twice daily (OTD: Oxygesic/OxyContin, Mundipharma).

Design And Methods: A randomized, double-blind, multicenter, cross-over, non-inferiority study was conducted in patients (n = 68) with chronic malignant or non-malignant pain. The new OOD was compared to OTD at identical total daily doses (TDD: 40-120 mg/day) employing intensive, five times daily current pain (0-100 mm visual analog scale, VAS) and twice daily 12 h recalled pain assessments as well as safety parameters such as nausea and sedation (VAS) over 5 days for each treatment (after a 5 day run-in phase).