Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Percentage of Participants Satisfied With Pain Treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.
详细描述
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who complains of cancer pain
- •Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours
- •Participants with an estimated life expectancy of at least 2 months
- •Participants who are able to communicate with the investigator
- •Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period
排除标准
- •Participants participating in another clinical trial
- •Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse
- •Participants who have active skin disease, avoiding application of the transdermal system
- •Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease)
- •Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period
研究组 & 干预措施
Transdermal Therapeutic System (TTS)-Fentanyl D-trans
干预措施: Fentanyl D-trans (Drug)
结局指标
主要结局
Percentage of Participants Satisfied With Pain Treatment
时间窗: Day 29
Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.
次要结局
- Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans(Day 1 and Day 29)