Cancer-related pain (breakthrough pain)
Conditions
Interventions
investigational material(s)
Generic name etc : OVF
INN of investigational material : fentanyl
Therapeutic category code : 821 Synthetic narcotics
Dosage and Administration for Investigational materia
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who submitted informed consent 2)Patients aged 20 years or older at the time of acquisition of informed consent 3)Patients with cancer-related pain associated with histologically or cytologically confirmed malignant solid or hematological malignancies 4)Patients notified of their cancer 5)Patients with Eastern Cooperative Oncology Group(ECOG) performance status(P.S.) 0-2 or patients with ECOG P.S. 3 due to disturbance of motility (bone fracture, paralysis, etc.) 6)Patients who are expected to be alive at least 3 months. 7)Patients with well-controlled persistent pain who are tolerant to an around-the-clock (ATC) dose of oral morphine 30-1000 mg/day, or equivalent potent opioid administered for a period of 7 days or more before observation registration 8)Patients who are expected to have breakthrough pain controlled by standard rescue medications (Oral, intrarectal or intravenous/subcutaneous morphine preparation, intravenous fentanyl preparation or oral oxycodone preparation)at least once and not more than 4 times daily
Exclusion criteria
Exclusion criteria: 1)Patients hypersensitive to fentanyl or other opioids 2)Patients receiving subarachnoidal opioids 3)Patients with grade 2-4 findings of stomatitis or dry mouth (clinical examination or functional/symptomatic) . For the stomatitis (clinical examination ), it is limited to that on either side of the buccal cavity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity Difference | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Relief and safety etc | — |
Outcome results
None listed