- 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
- 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
- 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.
- Have experienced intolerable adverse reactions (as defined in Attachment 3) during
the confirmatory trial.
- Have met any of the exclusion criteria applicable at the time of giving written
informed consent, those applicable at the time of randomization, or subject
withdrawal criteria in the confirmatory trial.
- Serious respiratory dysfunction.
- Serious bradyarrhythmia.
- Serious hepatic dysfunction.
- Serious renal dysfunction.
- Susceptibility to respiratory depression due to conditions such as increased
intracranial pressure, head injury and brain tumor.
- Patients who have a history of clinically significant adverse reactions to the
combination of opioid analgesics and any of the following drugs/substances, and who
are currently receiving or expect to receive any of them during the study:
Central nervous system depressants (phenothiazines, benzodiazepines and barbiturates),
inhalation anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, skeletal
muscle relaxants, antihistamines, ritonavir, alcohol, itraconazole, amiodarone,
clarithromycin, diltiazem, and fluvoxamine.
- History of convulsive seizures (except a single episode of infantile febrile
- History of hypersensitivity to fentanyl.
- Pregnant or lactating women, possibly pregnant women, or women who are planning to
- Patients who are judged by the investigator/subinvestigator to be inappropriate for