A Comparative Study of KW-2246

Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)

This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.

Inclusion Criteria:

• Written informed consent
• Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
• Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
• ECOG PS =< 3

Exclusion Criteria:

• Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
• Severe respiratory dysfunction
• Asthma
• Severe bradyarrhythmia
• Severe hepatic function disorder
• Severe renal function disorder
• Severe psychoneurotic disorder
• Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor