A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Dose of Instanyl
研究概览
简要总结
The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GENISIS
干预措施: Instanyl (Intranasal Fentanyl) (Drug)
结局指标
主要结局
Dose of Instanyl
时间窗: during therapy with Instanyl (planned: 28 days)
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
时间窗: before and after therapy with Instanyl (first/last visit)
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
时间窗: before and after therapy with Instanyl (first/last visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
时间窗: after therapy with Instanyl (planned: 4 weeks)
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
时间窗: after therapy with Instanyl (at last visit)
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
时间窗: before and after therapy with Instanyl (first/last visit)
Scale: 0=no, 1=low, 2=medium, 3=high
次要结局
- Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End(after therapy with Instanyl (planned: 4 weeks))
- Patient: How Many Episodes of Pain You Experience on Average?(initial visit (before start of therapy with Instanyl))
- Patient: Description of Pain at Initial Visit(initial visit (before start of therapy with Instanyl))
- Patient: How do You Feel Today?(before and after therapy with Instanyl (first/last visit))
- Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?(before and after therapy with Instanyl (first/last visit))
- Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)(before and after therapy with Instanyl (first/last visit))
- Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)(before and after therapy with Instanyl (first/last visit))
- Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20(before and after therapy with Instanyl (first/last visit))
- Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)(before and after therapy with Instanyl (first/last visit))
- Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5(before and after therapy with Instanyl (first/last visit))
- Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End(after therapy with Instanyl (planned: 4 weeks))
- Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)(before and after therapy with Instanyl (first/last visit))
- Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)(after therapy with Instanyl (planned: 4 weeks))
- Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)(after therapy with Instanyl (at last visit))
- Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End(after therapy with Instanyl (planned: 4 weeks))
- Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)(after therapy with Instanyl (first/last visit))
- Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)(after therapy with Instanyl (at last visit))
- Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...(after therapy with Instanyl (last visit))