NCT02084355

Trial name or title	Study Efficacy and Safety of Opioid Rotation Compared with Opioid Dose Escalation in Patients with Moderate to Severe Cancer Pain ‐ Open Label, Randomized, Prospective Study
Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: supportive care
Participants	People with cancer pain Inclusion criteria: aged > 18 years; being treated with 1 strong opioid including oral oxycodone, oral hydromorphone or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose; moderate to severe cancer pain (numeric rating scale > 3) at screening; uncontrolled adverse effects associated with currently applied opioid. Exclusion criteria: previous opioid rotation; unable to take oral medication; life expectancy < 1 month; newly started chemotherapy or radiotherapy (or both) within past 2 weeks of screening; serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase > 2.5 times of upper normal limit; serum total bilirubin or creatinine > 1.5 times of upper normal limit.
Interventions	Oral oxycodone Oral hydromorphone Fentanyl patch
Outcomes	Not described in the registration record.
Starting date	April 2014
Contact information	Se‐Il Go; Tel: +82 55 750 9454 ext 9454; Email: gose1@hanmail.net
Notes	Estimated completion date: January 2016