A Safety and Efficacy Study of OROS Hydromorphone HCL in Patients With Cancer-related Pain

• Patient assessment of pain at its worst in the last 24 hours, included as an item in the Brief Pain Inventory (BPI) Short Form, where 0=no pain and 10=pain as bad as you can imagine. [ Time Frame: At endpoint (the last recorded value obtained up to the end of the study (Day 29 +/-1 day) ] [ Designated as safety issue: No ]
  

• Other assessments of pain severity and pain relief from the BPI (Short Form) [ Time Frame: From Day 1 (baseline/randomization) to the last recorded value obtained up to the end of the study (Day 29 +/-1 day) ] [ Designated as safety issue: No ]
  
• Number of breakthrough pain medication doses taken [ Time Frame: From Day 1 in the titration phase up through the end of the study (Day 29 +/-1 day) ] [ Designated as safety issue: No ]
  
• Number of patients with treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation from the study [ Time Frame: From Day 1 in the titration phase up through the end of the study (Day 29 +/-1 day) ] [ Designated as safety issue: No ]
  

This is a randomized (patients assigned by chance to receive 1 of 2 study drugs), double-blind (neither the patient nor the investigator will know the identity of the assigned treatment) study in China to evaluate the safety and efficacy of OROS hydromorphone hydrochloride (HCl) administered once-daily compared with oxycodone HCl controlled-release (CR) administered twice daily in adult patients with cancer pain who require the use of strong oral opioid (narcotic) analgesics (pain relievers related to morphine). The study consists of a screening period of up to 14 days before treatment to determine patient eligibility for the study. Approximately 260 adult patients meeting entry criteria will enter the dosage titration period of the study and over a period of 2 to 8 days will be converted from their current opioid medication to an appropriate dosage of study drug (OROS hydromorphone HCl or oxycodone CR HCl). To prevent the investigator and the patient from knowing the assigned treatment, 2 capsules of study drug and/or dummy placebo will be self-administered by all patients twice daily at 12-hour intervals. Dummy placebo capsules will be identical in appearance to capsules of study drug but will not contain active drug. Once an appropriate starting dosage of study drug is determined for a patient, the patient will be treated for 28 days (referred to as the maintenance period of the study). Patients will be instructed to take study drug (includes dummy placebo capsules) orally (by mouth) twice daily beginning in the morning (doses are to be taken once every 12 hours). Patients will be required to report to the study clinic for up to 10 times during the study to have required study procedures and laboratory tests performed (additional visits may be required). During the 28 day treatment period (referred to as the maintenance period of the study), patients may have their dosage of study drug adjusted (increased or decreased) to obtain the best balance between pain relief and opioid-related side effects. If patients experience sudden episodes of pain (referred to as Breakthrough pain) during treatment with study drug (ie, during the time between doses) they will be permitted to take a single oral dose of morphine hydrochloride every 4 hours as needed to control the pain. During the study, pain experienced by patients will be assessed by the use of a questionnaire (referred to as the Brief Pain Inventory [BPI] Short Form) that will rate pain on a scale of 0 to 10 where a score of 0 is no pain and a score of 10 is pain as bad as you can imagine. In addition, patient safety will be assessed during treatment by monitoring for adverse events and by evaluating results obtained from clinical laboratory tests, electrocardiograms, vital signs measurements and physical examinations. Two capsules containing tablets of study drug and/or dummy placebo will be self-administered orally, twice daily, at 12-hr intervals by patients for up to 36 days. Patients will receive treatment with either OROS hydromorphone HCL at a starting dosage of 8mg/day to be increased up to a maximum total daily dosage of 32mg/day OR patients will receive oxycodone HCL CR at a starting dosage of 10mg twice daily to be increased to a maximum total daily dosage of 80mg (ie, 40mg twice daily).