Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Chronic Non-Malignant Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain Intensity Rating at Day 15
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 patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pain.
详细描述
This is an open label (all people know the identity of the intervention), single arm study to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic non-malignant pain (except for headaches or central spinal cord mediated pain). The study will consist of 2 phases: stabilization phase (up to 7 days before starting the treatment) and treatment phase (30 days). The first patch will be applied by Investigator then by participants themselves until 30 days. All participants will start the treatment with patch releasing 25 micrograms per hour (mcg/h) of fentanyl . The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose can be titrated (slow increase in drug dosage, guided by participant's responses) as per participant's need. The duration of the treatment will be 30 days after first patch application. The dose of TTS-fentanyl can be slowly increased if needed, by 25 mcg/h to achieve adequate pain control. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate TTS-fentanyl dose titration. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be Day 0 (Baseline), Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by Investigator and participants. 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 with chronic non-malignant pain (of any etiology except for headaches or central spinal cord mediated pain) with moderate (medium level of seriousness) to severe (very serious, life threatening) pain that requires treatment with a potent opioid
- •Participants must also be currently treated with short or long acting opioid medications other than Transdermal Therapeutic System (TTS)-fentanyl at a dose less than or equal to 134 milligram per day (mg/day) of oral morphine (or an equianalgesic dose of another opioid), participants may have been treated with TTS-fentanyl in the past
- •Participants who had side effects after receiving Non Steroidal Anti-inflammatory Drugs (NSAIDs)
- •Participants who failed from other treatments such as operation or lack of efficacy of current treatment
- •Participants with spinal cord stimulators may enroll, provided that they turn the spinal cord stimulator off for the duration of the trial, or leave it continually on for the duration of the trial
排除标准
- •History of allergy, hypersensitivity, or lack of ability to tolerate fentanyl
- •Skin disease that precludes the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
- •History or suspicion of alcohol or drug abuse within the past 5 years
- •History of narcotic (strong habit-forming drug that stops pain and depresses the central nervous system) therapy
- •Pregnancy or breast-feeding female
研究组 & 干预措施
Transdermal Therapeutic System (TTS)-fentanyl
Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. Oral morphine syrup is allowed to titrate the dose of TTS-fentanyl. The study duration will be 30 days after first patch application.
干预措施: TTS-Fentanyl (Drug)
Transdermal Therapeutic System (TTS)-fentanyl
Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. Oral morphine syrup is allowed to titrate the dose of TTS-fentanyl. The study duration will be 30 days after first patch application.
干预措施: Morphine (Drug)
结局指标
主要结局
Change From Baseline in Pain Intensity Rating at Day 15
时间窗: Baseline and Day 15
Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.
Change From Baseline in Pain Intensity Rating at Day 30
时间窗: Baseline and Day 30
Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.
次要结局
- Number of Participants With Investigator's Global Assessment(Day 30)
- Number of Participants With Participant's Global Assessment(Day 30)