Pain, Cancer
Conditions
Keywords
Pain, Cancer
Brief summary
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
Interventions
KW-2246 (fentanyl citrate)
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent to participate in the study on a voluntary basis. * Patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial. * Outpatients who live with a caregiver such as a family member, or inpatients. * Require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator. * Performance Status (ECOG) of 3 or less at the time of giving written informed consent. * Have a life expectancy of at least three months as determined by the investigator. * Be able to receive diary training and have been able to properly complete diaries during the confirmatory trial.
Exclusion criteria
* Have experienced intolerable adverse reactions (as defined in Attachment 3) during the confirmatory trial. * Have met any of the
Countries
Japan
Outcome results
None listed