ObjectiveTo evaluate the efficacy and safety of oxycodone hydrochloride controlled-release (CR) tablets (Oxycontin®, Mundipharma International Limited, Cambridge, UK), 5 mg, 10 mg, 20 mg, and 40 mg in relieving moderate to severe non-cancer pain.Method
Two multi-center, open-label, prospective, self-controlled clinical trial, used identical protocols. All the subjects were patients with moderate to severe non-cancer pain. The clinical data were collected in the natural course of clinical treatment.
Results
Treatments with oxycodone CR tablets was associated with fast onset on pain relief; 85.2 % of patients in study 1 and 91.8 % of patients in study 2 achieved pain relief within 1 hour of drug administration.
Clinical efficacy
Both studies demonstrated that oxycodone CR tablets showed good clinical efficacy for relieving both moderate and severe non-cancer pain. Patients experienced sustained pain relief from the first week of treatment. Patients in both study 1 and study 2 experienced a dramatic pain score reduction (as assessed by VAS) after the first week of treatment.
Safety profile
During oxycodone CR treatment, use of concomitant medications decreased significantly. A few patients developed ADRs in the first week, which decreased significantly as the treatment continued. Constipation was the most common ADR in the first week, which decreased to 10 % of patients from the second week of treatment.
Conclusion
Oxycodone CR tablets demonstrated fast onset of pain control and superior efficacy for relieving both moderate and severe non-cancer pain, as well as significant reductions in the number of concomitant medications, demonstrating a good safety profile.
