Trial Information

Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency

This clinical trial consists of patient screening, two- week efficacy and safety evaluation
phase and twelve-week extension phase. During the patient selection period, potential
patients will take previously administered oral opioid analgesic, and patients eligible for
participation in this clinical trial at the second visit will receive the study drug for two
weeks. At investigator discretion, patients completing 2 weeks of treatment with study
drug can be enrolled into the extension phase. The sample size of this study is 120. The
study population is the patients administered with only the oral opioid analgesic for cancer
pain treatment, and administered with the immediate opioid analgesic for breakthrough pain
more than twice a day on average for the three days prior to the 2nd visit. Efficacy and
safety evaluation phase: Potential patients determined for participation in the study during
the 1st visit and administered with oral strong opioid analgesic ¿(not the study drug¿)
until the 2nd visit and with immediate-release opioid analgesic whenever breakthrough pain
is present. From the 2nd visit to the 4rd visit, Hydromorphone HCl Oral Osmotic push-pull
System (Oral Osmotic push-pull System: Each Push-Pull hydromorphone tablet comprises a
semi-rigid, non-dissolvable membrane enclosing a layered core. A drug layer contains
hydromorphone and excipients. A 'push' layer contains osmotic agents. A precision
laser-drilled hole serves as the delivery orifice in the GI tract. Fluid flows across the
semi-permeable membrane at a controlled rate, causing (1) hydromorphone to go into
suspension (2) the osmotic layer to swell. As the expanding osmotic layer pushes against
the drug layer, hydrated hydromorphone flows out of the delivery orifice at the same rate as
fluid enters the core. The depleted membrane does not dissolve and the shell is excreted
intact in the feces. Study drug is administered once a day for two weeks. The dose of study
drug is flexible and will increase or decrease based on the frequency of immediate-release
opioid analgesic doses needed to manage pain. In the Extension-Safety Evaluation phase, the
dose of study drug will be determined by the investigator's discretion based on final dosage
at efficacy and safety evaluation phase and patient's condition. If patients want to take
study drug for the extension phase after signing the informed consent form, the investigator
will collect safety information including adverse events for 12 weeks. At second visit,
initial dose of hydromorphone will be determined according to the equivalent analgesic
effect conversion table (oxycodone 10mg twice/day is equal to hydromorphone HCl 8mg
once/day). Fow two weeks (efficacy and safety evaluation phase of the study), patients
will take hydromorphone at 10 AM daily. Change of Hydromorphone dose: The investigator will
increase a patient's daily dose if more than 3 breakthrough pain episodes require rescue
medication within a 24 hours period