NCT05209906已完成不适用
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percentage of patients requiring dose titration
研究概览
简要总结
An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
- •a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer;
- •at least partial relief of breakthrough pain by use of opioid therapy;
- •able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;
- •willing and able to complete patient diary with each pain episode.
- •20 to 80 years of age;
排除标准
- •rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
- •history of hypersensitivity or intolerance to fentanyl;
- •cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
- •psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
- •Severe (Grade 4) mucositis (subjects with less than severe mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
- •abnormal oral mucosa which will impede drug absorption;
- •recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
- •use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study;
- •pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
结局指标
主要结局
Percentage of patients requiring dose titration
时间窗: At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years
Percentage of patients requiring dose titration
次要结局
- Pain intensity changes at 5, 10, 15, 30 minutes after dosing(At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years)
- Subjects' satisfaction(At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years)
研究者
Yi-Shing Leu
Head of Otorhinolaryngology Department (ENT)
Mackay Memorial Hospital
研究点 (1)
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