An Open-label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percentage of Participants Dropped From Study due to Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized study to evaluate the efficacy and safety of low-dose TTS-fentanyl in Taiwan participants with cancer pain. Eligible participants will be enrolled and scheduled to return at Day 0, 7, 14 and 28. Participants will receive TTS-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). Dose of fentanyl can increased or decreased as per Investigator's discretion to maintain participant's pain score at 2 or less on the Brief Pain Inventory (BPI) question 6 (that tells how much pain you have right now). Safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. Participants' 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues)
- •Participants who are able to communicate effectively with study personnel
- •Participants who have intolerable cancer pain (pain score greater than or equal to [>=] 4)
- •Participants who have an estimated life expectancy of at least 30 days
- •Participants who have given written dated informed consent to participate in the study
排除标准
- •Participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy [opiates]), for their pain before entering the study
- •Participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study
- •Participants with significant abnormalities in hepatic or renal function which would, in the opinion of the Investigator, prevent the participants involvement in the study
- •Participants with significant clinical abnormalities in central nervous system (CNS), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study
- •Pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception
研究组 & 干预措施
Transdermal Therapeutic System (TTS)-Fentanyl
干预措施: Transdermal Therapeutic System (TTS)-Fentanyl (Drug)
结局指标
主要结局
Percentage of Participants Dropped From Study due to Adverse Events
时间窗: Day 0 up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.
次要结局
- Brief Pain Inventory (BPI) Score (Question 6)(Day 0, Day 7, Day 14 and Day 28)
- BPI Score (Question 9) - Quality of Life (QOL)(Day 0, Day 7, Day 14 and Day 28)
- Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl(Day 0 up to Day 28)
- Investigator's Global Assessment Scale Score(Day 0 and Day 28)
- Percentage of Participants With Treatment Satisfaction(Day 0 and Day 28)