Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

Exclusion Criteria

• •1. Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
• •2. Female patients who are pregnant or lactating;
• •3. Patients requiring opioid at doses equivalent to \< 20 mg/day or \> 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
• •4. Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]);
• •5. Patients who are contraindicated for the use of opioids;
• •6. Patients who are currently being maintained on methadone for pain;
• •7. Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;
• •8. Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices;
• •9. Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.