A Comparative Study of KW-2246
Phase 3
Completed
- Conditions
- Cancer Related Pain (Breakthrough Pain)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01326689
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description KW-2246 KW-2246 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Pain intensity difference 30 minutes after each dose Pain scores on the visual analog scale
- Secondary Outcome Measures
Name Time Method