A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0
研究概览
简要总结
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a 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 to 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
Lower Dose Fentanyl
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
干预措施: Fentanyl (Drug)
Higher Dose Fentanyl Sublingual Spray
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
干预措施: Fentanyl (Drug)
Placebo
Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours.
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 (NRS SPID-48) After Time 0
时间窗: Over 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 Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0(Baseline, 1, 16, and 24 hours)
- NRS Pain Intensity Score at Each Scheduled Time Point After Time 0(Baseline, 1, 16, and 24 hours)
- NRS SPID After Time 0(Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24))
- Total Pain Relief (TOTPAR) After Time 0(Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48))
- Time to Onset of Analgesia(Within 48 hours)
- Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)(2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia)
- Peak Pain Relief From Time 0 (First Dose of Study Medication)(Within 48 hours after Time 0)
- Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)(Within 48 hours after Time 0)
- Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)(Within 48 hours after Time 0)
- Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)(Within 48 hours after Time 0)
- Number of Participants Using Rescue Medication(Within 48 hours)
- Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)(Within 48 hours)
- Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours(Over 0 to 24 hours; Over 0 to 48 hours)
- Participant Global Evaluation of Study Drug(Within 48 hours)