Cancer Related Pain (Breakthrough Pain)
Conditions
Brief 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.
Interventions
DRUGKW-2246
Rescue medication at an optimal dose, which is determined by dose titration
DRUGPlacebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity difference | 30 minutes after each dose | Pain scores on the visual analog scale |
Countries
Japan
Outcome results
None listed