Open-label study to evaluate the efficacy, safety, and pharmacokinetics of switching from oxycodone hydrochloride tablets to S-8117OTR in patients with chronic pain

Abstract

Objective: The study evaluated the efficacy, safety, and pharmacokinetics before and after a switchover from oxycodone hydrochloride controlled-release tablet to S-8117OTR in patients with moderate to severe chronic pain. Method: This study was a multicenter, non-randomized, open-label design that enrolled patients with moderate to severe non-cancerous chronic pain at 27 study sites nationwide. The primary endpoint was defined as the percentage of patients that maintained pain control during the switchover treatment phase. Results: A total of 81 patients were enrolled. Among them, 61 patients entered the switchover phase, and 44 patients completed the study. The primary endpoint, the percentage of patients that maintained pain control [95％ confidence interval] was 80.3％ [68.2, 89.4]. Treatment related adverse events reported ≧5％ were constipation, nausea, somnolence, and vomiting. None of the patients were considered as drug dependence. Conclusion: There was no significant difference in efficacy, safety and pharmacokinetics before and after switching from oxycodone hydrochloride controlled-release tablet to S-8117OTR.