A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 主要终点
- Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
研究概览
简要总结
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets protocol-specified criteria for qualification and contraception
- •Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
- •Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.
排除标准
- •History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- •the analysis of results
研究组 & 干预措施
Buprenorphine 0.5 mg TID
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
干预措施: Buprenorphine Sublingual Spray (Drug)
Buprenorphine 0.5 mg TID
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
干预措施: Placebo (Drug)
Buprenorphine 1.0 mg BID
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
干预措施: Buprenorphine Sublingual Spray (Drug)
Buprenorphine 1.0 mg BID
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
干预措施: Placebo (Drug)
Buprenorphine 1.0 mg TID
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
干预措施: Buprenorphine Sublingual Spray (Drug)
Buprenorphine 1.0 mg TID
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
干预措施: Placebo (Drug)
Placebo
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
干预措施: Placebo (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
时间窗: Baseline and 0 to 48 hours after Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
次要结局
- NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0(Baseline and 4, 8, 24 and 48 hours after Time 0)
- NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)(Baseline and 0 to 4 hours after Time 0)
- NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)(Baseline and 0 to 8 hours after Time 0)
- NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0(4, 8, 24 and 48 hours after Time 0)
- NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)(Baseline and 0 to 24 hours after Time 0)
- Percentage of Participants Who Used Rescue Medication for Pain(From Time 0 (first dose of study drug) up to Day 9)