A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 4
- 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
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
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
- •Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
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 (under the tongue) spray three times daily (TID) for two days.
干预措施: Buprenorphine (Drug)
Buprenorphine 0.25 mg TID
Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
干预措施: Buprenorphine (Drug)
Buprenorphine 0.125 mg TID
Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
干预措施: Buprenorphine (Drug)
Placebo
Participants received placebo-matching buprenorphine sublingual spray TID 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
- Time to First Use of Rescue Medication for Pain(From Time 0 to time of first use of rescue medication (up to 280 minutes))
- 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)
- Percentage of Participants With Peak Scores in Each Pain Relief Category(From Time 0 (first dose of study drug) up to 48 hours)
- Time to First Perceptible Pain Relief(From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes))
- Time to Meaningful Pain Relief(From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes))
- NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0(Baseline and 0 to 4, 0 to 8 and 0 to 24 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)
- Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0(4, 8, 24 and 48 hours after Time 0)
- Time to Onset of Analgesia(From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes))
- Percentage of Participants Using Rescue Medication for Pain(From Time 0 (first dose of study drug) up to 48 hours)
- Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours(Over 24 and 48 hours after Time 0 (first dose of study drug))
- Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0(4, 8, 24 and 48 hours after Time 0 (first dose of study drug))
- Time to Peak Pain Relief(From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes))
- Participant's Global Evaluation of Study Drug(End of treatment (Day 3) or early termination)