A Pilot, Randomized, Double-blind, Placebo-controlled Single-center Study to Evaluate the Safety and Efficacy of SUBSYS™ (Fentanyl Sublingual Spray) for the Treatment of Acute Procedure-related Pain in a Monitored Setting
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable
研究概览
简要总结
Participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. They will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication.
Participants may take pain killers at any time after the procedure for pain relief. They will be given a diary card, which they will take home. They will record the name of the medication taken, the time, and dosage.
The study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site.
详细描述
Participants will be separated into opioid-experienced and opioid-naïve groups. Participants in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray (FSS) or a matching placebo sublingual spray (PSS) 10 minutes before the scheduled procedure. Based on FDA guidelines, opioid-experienced FSS participants will receive FSS 400 µg, and opioid-naïve FSS participants will be further randomized in a 1:1 ratio to receive either 100 µg or 200 µg. All participants randomized to placebo receive the same matching PSS, regardless of opioid experience. Pain and sedation will be recorded multiple times during the scheduled procedure. If rescue medication is needed during the procedure, local anesthetic standard of care for the procedure will be administered and recorded in the study record. Efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and between the treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Has scheduled an interventional procedure for treatment of pain without sedation
- •Has cleared pre-operative assessment
- •Is able to read or understand informed consent form, and gives consent to participate in the study
排除标准
- •Is taking any form of fentanyl
- •Has oral pathology that would prevent effective absorption of study medication
- •Was treated with an investigational drug within protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), 3) the analysis of results
研究组 & 干预措施
ON FSS 100 µg
Participants classified as opioid-naïve (ON), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, and further randomized to a dose of 100 µg
干预措施: Fentanyl Sublingual Spray (FSS) (Drug)
ON FSS 200 µg
Participants classified as opioid-naïve (ON), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, and further randomized to a dose of 200 µg
干预措施: Fentanyl Sublingual Spray (FSS) (Drug)
OE FSS 400 µg
Participants classified as opioid-experienced (OE), randomized to receive one dose of fentanyl sublingual spray (FSS) 10 minutes before treatment procedure, at a dose of 400 µg
干预措施: Fentanyl Sublingual Spray (FSS) (Drug)
ON PSS
Participants classified as opioid-naïve (ON) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure
干预措施: Placebo Sublingual Spray (PSS) (Drug)
OE PSS
Participants classified as opioid-experienced (OE) and randomized to receive one dose of matching placebo sublingual spray (PSS) 10 minutes before treatment procedure
干预措施: Placebo Sublingual Spray (PSS) (Drug)
结局指标
主要结局
Pain scored on a scale from 0 to 10, where 0 = no pain and 10 = the most intense pain imaginable
时间窗: within 24 hours
次要结局
- Sedation scored on a scale from 0 to 4, where 0 = awake/alert and 4 = unarousable(within 24 hours)