Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
Phase 3
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Cancer Related Pain (Breakthrough Pain)
Both
Cancer Related Pain (Breakthrough Pain)
Trial Information
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Pain intensity difference
Outcome Description:
Pain scores on the visual analog scale
Safety Issue:
No
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
2246-004
NCT ID:
NCT01326689
Start Date:
March 2011
Completion Date:
Related Keywords:
- Cancer Related Pain (Breakthrough Pain)
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