NCT00355628已完成2 期
Phase II Clinical Study of KW-2246 in Patients With Cancer Pain - Maintenance Switch Study in Oral Morphine or Oral Oxycodone-treated Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients.
详细描述
This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent to participate in the study.
- •Be able to be hospitalized.
- •Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
- •Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
- •Not have experienced intolerable toxicity for 2 days before study entry.
- •Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
- •Have a life expectancy of at least 1 month after the start of KW-2246 administration.
- •Considered to be able to keep the patient diary.
排除标准
- •Serious respiratory dysfunction.
- •Serious bradyarrhythmia.
- •Serious hepatic or renal dysfunction.
- •Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
- •History of convulsive seizures (except a single episode of infantile febrile convulsions).
- •Current or past history of drug dependence or narcotic abuse.
- •Dry mouth that affects oral intake.
- •Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
- •Use of narcotic antagonists within 7 days prior to study entry.
- •Interventions that may affect pain evaluation, such as surgery, radiation to the pain site (including those sites that influence pain) and nerve block, within 7 days prior to study entry or scheduled to be given during the study.
- •Patients with a history of serious adverse reactions to the combination of opioid analgesics and other drugs/substances who are currently receiving or expected to receive those drugs/substances combined to opioid analgesics.
- •History of hypersensitivity to fentanyl.
- •Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
- •Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
- •Prior exposure to KW-
- •Patients whom an investigator judge unsuitable for enrollment.
研究组 & 干预措施
1
Experimental
KW-2246 (fentanyl citrate)
干预措施: KW-2246 (fentanyl citrate) (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: At every visit
Pain Intensity as Rated on a Categorical Scale
时间窗: At specified visits
次要结局
- Pain Intensity as Rated on a Visual Analog Scale (VAS)(At specified visits)
- Number of Rescue Doses per Day(At every visit)
- Regular Dose Level of KW-2246(At every visit)
研究者
研究点 (1)
Loading locations...
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