A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
研究概览
简要总结
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.
Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
详细描述
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.
Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients who are 40 years of age or older.
- •Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
- •Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).
排除标准
- •Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- •Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.
- •Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II.
- •Patients who have used any illicit drugs of abuse within five years before the start of the study.
- •Patients who have abused any prescription medication or alcohol within one year before the start of the study.
- •Patients with an allergy or hypersensitivity to opioids.
- •Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
- •Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
研究组 & 干预措施
sufentanil sublingual tablet 30 mcg
sufentanil sublingual tablet 30 mcg
干预措施: sufentanil sublingual tablet 30 mcg (Drug)
结局指标
主要结局
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
时间窗: 12-hours
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
次要结局
- Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"(12 hours or at patients' termination from study)
- Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).(1 hours)
- Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"(12 hours or until patients' termination from study)