A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the safety and tolerability based on the incidence of adverse experiences of buprenorphine sublingual spray (0.5 milligrams [mg] three times daily [TID]) compared with standard post-operative narcotic therapy in participants with postoperative pain. Standard post-operative narcotic therapy is defined as morphine intravenous (IV) injection (4 mg TID) followed by oxycodone hydrochloride tablet (10 mg TID).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
Buprenorphine Sublingual Spray 0.5 mg
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
干预措施: Buprenorphine Sublingual Spray (Drug)
Buprenorphine Sublingual Spray 0.5 mg
Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
干预措施: Zofran (Drug)
Standard of Care Narcotic Therapy
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
干预措施: Morphine (Drug)
Standard of Care Narcotic Therapy
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
干预措施: Oxycodone Hydrochloride (Drug)
Standard of Care Narcotic Therapy
Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
干预措施: Zofran (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Days 1 to 8
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.
次要结局
- Percentage of Participants Provided Rescue Medication for Nausea(Days 1 to7)
- Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)(Days 1 to 7)
- Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days(0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days)
- Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours(90 Minutes,12, 24, 48 and 72 Hours)
- Number of Participants With Abnormal Oral Cavity Examinations(Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8)
- Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours(Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose)