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The purpose is to evaluate the clinical efficacy of Hydromorphone HCl ORal Osmotic System by assessing the degree of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl ORal Osmotic System in Korean cancer patients.
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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hydromorphone HCl OROS
Janssen Korea, Ltd., Korea
Published on BioPortfolio: 2014-08-27T03:18:15-0400
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