A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
研究概览
简要总结
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
详细描述
The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.
Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.
Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.
Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.
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
- •Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
- •Patients classified as American Society of Anesthesiologists (ASA) class I-III
- •Patients who are willing and capable of understanding and cooperating with the requirements of the study.
- •Patients able to understand and communicate in English.
- •Patients who have provided written informed consent and signed the IRB approved consent form.
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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- •Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) 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 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).
- •Female patients who are pregnant (positive pregnancy test) or breastfeeding.
- •Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
- •Patients who present to the ER using supplemental oxygen.
- •Patients who have participated in a clinical trial of an investigational drug or device within 30 days of enrollment.
- •Patients who are active or reserve duty with the US military.
研究组 & 干预措施
sufentanil sublingual tablet 30 mcg
Patients may be administered one tablet every 60 minutes as needed during the study period
干预措施: sufentanil sublingual 30 mcg tablet (Drug)
结局指标
主要结局
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
时间窗: One hour
The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity \[PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.
次要结局
- TOTPAR1 (Time-weighted)(1-hour)
- PI at Each Evaluation Time Point(5 hours)