A Comparative Study of KW-2246

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

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