Trial Information

An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients

The primary purpose of this observational study is to collect clinical data on cancer pain
control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the
clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the
effectiveness of cancer pain control and any adverse events reported by those patients using
OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone
will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and
end-of-dose failure before and after the study drug administration and examining the
patient's satisfaction with study drug and the investigator's global assessment. This is a
multi-center, open-label, prospective, exploratory, and observational study with
approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference
between before and after the treatment. Since this is an observational study under the
condition of routine practice, OROS Hydromorphone dosage should be adjusted at the
discretion of the investigator, based on patient response. It is recommended that the dosage
be conservative at first and adjusted appropriately considering the adverse events and
analgesic effect for all the patients.